About Shields Pharma Inc.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

We offer Laboratory R&D and QC testing services as well as production and formulation of psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD, and problematic substance abuse.

Shields Pharma Inc. is an equal opportunity employer committed to diversity and inclusion for everyone. We are continuously looking for smart-minded, skilled, qualified, experienced, independent, reliable and detail-oriented candidates to join our successful team.

Our people are at the heart of everything we do.

You can count on;

• Safety as our first core value
• Integrity
• Accountability
• Continuous training and skill development

We are currently looking for a Senior Quality & Compliance Specialist to join our growing team!

Position Title: Senior Quality and Compliance Specialist (Full-time)

Reports To: Head of Quality & Compliance department

Job Description:

The Senior Quality and Compliance Specialist is a technical expert in Quality Assurance, responsible for planning and execution of Quality Assurance deliverables, while overseeing and evaluating the technical aspects of the work performed by the department.

You will use your expertise and skills to ensure the Quality and Compliance department performance and service meets the highest quality, regulatory and industry standards.

As a Senior Quality and Compliance Specialist you should have a sound knowledge of pharmaceutical cGMP, GxPs, GDP, ICH, FDA CFR 211, ALCOLA+, etc. guidelines and regulations.

This position relies heavily on a comprehensive understanding of laboratory operations, analytical methods and instrumentation including general wet chemistry and instrumentation such as LC/MS/MS, HPLC, GC-Headspace, GC/MS, ICP-MS and Dissolution. We are seeking a motivated individual with a pharmaceutical quality assurance background to play a critical role and provide quality oversight on processing of all internal & external GxP documentation. This position reports to the Head of Quality & Compliance department.

Duties shall include, but are not limited, to the following:

• Ensuring the company processes, procedures and policies are complying with current Health Canada, US FDA, WHO, and European Good Manufacturing Practices (GMPs), GxPs, ICH, MHRA, ALCOLA+ guidelines and regulations.
• Prioritizing and managing compliance projects.
• Supporting the maintenance and improvement to quality systems and processes as needed.
• Developing GMP documentation such as SOPs, forms, protocols, reports, etc.
• Demonstrating sound knowledge of operation of analytical and quality control activities.
• Reviewing all laboratory documentation including lab reports, records of procedures, results and data analysis ensuring that they are accurate and in accordance with Good Documentation Practices (GDP) guidelines.
• Reviewing laboratory methods, analytical data, calibration and validation reports/protocols.
• Leading laboratory investigations from initiation to closure of investigation.
• Preparing and approving analytical test results CoAs.
• Leading, conducting and/or participating in deviations, laboratory OOS and OOT investigations, managing change controls, CAPA and customer complaints
• Managing and delivering company’s training program.
• Lead and coordinate Shields Pharma Inc. inspection programs including; internal audits, client and supplier audits and regulatory inspections.
• Management of quality systems, batch document review and product release related to the manufacturing of final products.
• Providing inspection readiness support including front room and backroom activities.
• Working with cross functional stakeholders to ensure follow-up of quality issues.
• Ensure equipment/instrument qualifications, calibrations, repairs and maintenance documentations are up-to-date and archived.

Job Requirements: (Work Status, Qualification, Knowledge, and Experience)

• Must possess Permanent Canadian residency with work permit and/or Canadian citizenship.
• Must be living in Canada, preferably in Toronto area
• Minimum Science degree in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines.
• Minimum of 4 years of direct and hands-on experience working in pharmaceutical QA environment.
• Should demonstrate strong people management, Interpersonal and decision-making skills.
• Sound knowledge of pharmaceutical analytical method development, method validation, investigational studies, method transfer, stability studies and preparation/execution of protocols, etc.
• Well versed in understanding of USP, BP, EP, and JP methods and specifications.
• In-depth knowledge and competency in cGMP/GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), GXP, FDA CFR 211, ICH, and ALCOLA+ regulation and quality system guidelines.
• Be able to conduct laboratory investigation and other quality attributes (e.g. SOP development, Change Control, Deviation, Root Cause investigation and analysis, CAPA, etc.).
• Experienced in creating, and reviewing batch records
• Track record of multi-tasking, being detail-oriented, trouble-shooting/problem solving abilities, working with minimal instruction on routine work and moderate instruction on new assignments.
• Strong problem-solving skills, with sound judgment and the ability to make decisions independently while balancing business needs, quality and compliance risks.
• Strong organizational skills and the ability to manage multiple tasks and responsibilities in a dynamic work environment
• Be able to work in a fast-paced environment with significant responsibilities and follow assignments through to completion to meet agreed timelines.
• Be a team player, punctual and have strong communication skills.
• Proficiency with MS office (Excel, Word, PowerPoint)

How To Apply:

Please reference “Senior Quality and Compliance Specialist” in subject line and submit resume with cover letter to hr@shieldspharma.com

The information collected to review your application will be processed by the human resources services

We welcome and encourage applications from all qualified applicants. We are committed to adhering to our company objectives and requirements outlined above. Kindly refrain from applying if you are not qualified.

We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.

No phone calls please.

About Shields Pharma Inc.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

We offer Laboratory R&D and QC testing services as well as production and formulation of certain psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD, and problematic substance. 

Shields Pharma Inc. is an equal opportunity employer committed to diversity and inclusion for everyone. We are continuously looking for smart-minded, skilled, qualified, experienced, independent, reliable, and detail-oriented candidates to join our successful team.

Our people are at the heart of everything we do.

You can count on;

• Safety as our first core value,
• Integrity,
• Accountability, and
• Continuous Training and skill development.

Position Title: Pharmaceutical Senior HPLC, GC/MS, and ICP-MS Analyst (Level III)

Reports To: Chief Scientific Officer and Laboratory Manager

Job Description:

The Senior HPLC, GC/MS, and ICP-MS Analys shall support both R&D and Quality Control analytical activities at Shields Pharma laboratory.

The Senior Analyst is responsible for conducting method development and validation, method transfer, assay and impurity analysis by utilizing HPLC, LC/MS, GC-Headspace, GC/MS, and ICP-MS, projects according to the schedule established by following the procedures and adhering to Good Manufacturing Practices (GMP), GXP, and good laboratory practices.

The successful candidate will be working in a very fast paced environment, performing both R&D and QC analysis of assigned raw materials, in-process, and final products as per established methods, current pharmacopoeias (e.g. USP, BP, EP, etc.), and the client’s methods and specifications within standard time-lines, and under minimal guidance/supervision.

This position relies heavily on comprehensive wet chemistry and strong chromatographic skills and competencies.

Duties shall include but are not limited to the following:

• Perform all works in accordance with all established company policies, protocols and procedures, and governing regulatory, GMP compliance, and safety guidelines.
• Perform assay and impurities method development, method validation, method transfer, cleaning validation, and stability testing.
• Maintain accurate documentation including lab reports, records of procedures, results, and data analysis in accordance with Good Documentation Practices (GDP) guidelines
• Provide scientific advice and training to junior analysts on laboratory instrumentation and methods.
• Perform peer review of analytical reports and data when requested.
• Document and report results in accordance with GMP and GLP
• Conduct Laboratory Investigation (OOS, OOT, Deviation, etc.).
• Provide technical support to other analysts when required
• Collaborate with cross-functional teams to support R&D projects.
• Ensure all general lab supplies (chemicals/non-chemicals) are available at all time.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all analytical documentation including lab reports, records of procedures, results, and data analysis are accurate and in accordance with Good Documentation Practices (GDP) guidelines.
• Provide oversight of external vendors who are delegated responsibilities when requested.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all generated documentation including lab reports, records of procedures, results, and data analysis are accurate and correct.
  
  

Job Requirements: (Work Status, Qualification, Knowledge, and Experience)

• Must possess Permanent Canadian residency with work permit and/or Canadian citizenship.
• Must be living in Canada, preferably in Toronto area
• Minimum M.Sc.  (min. 3 yrs. industry experience), or B.Sc. (min. 5 yrs. industry experience), preferably in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines.
• Must have worked minimum of 3 years (depending on the qualification) in pharmaceutical laboratory discipline.
• Must demonstrate solid technical knowledge and extensive expertise on operation, Qualification, trouble-shooting, and maintenance of sophisticated laboratory instrumentation and equipment including, LC/MS, UPLC, HPLC, GC-Headspace, GC/MS, and ICP-MS
• Must demonstrate expertise in analytical; method development, method validation, investigational studies, method transfer, stability studies, and preparation and execution of protocols,
• Should be well versed in understanding of USP, BP, EP, and JP, methods and specifications.
• Must have in-depth knowledge and competency in cGMP/GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), GXP, FDA CFR 211, ICH, and ALCOLA+ regulation and quality system guidelines.
• Should be able to conduct laboratory investigation and other quality attributes (e.g. SOP development, Change Control, Deviation, Root Cause investigation and analysis, CAPA, TAR, etc.)
• Proficiency to MS office (Excel, Word, PowerPoint)
• Track record of multi-tasking, being detail-oriented, trouble-shooting/problem solving abilities, working in a fast-paced environment with minimal instruction on routine work and moderate instruction on new assignments.
• Be punctual, team player, fast learner, and have strong Interpersonal and communication skills,
  
  

How To Apply:

Please reference “Senior Laboratory R&D and QC Analyst (Level III)” in subject line and submit resume with cover letter to hr@shieldspharma.com

We welcome and encourage applications from all qualified applicants. We are committed to adhering to our company objectives and requirements outlined above. Kindly refrain from applying if you are not qualified.

We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.

No phone calls please.

About Shields Pharma Inc.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

We offer Laboratory R&D and QC testing services as well as production and formulation of certain psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD, and problematic substance. 

Shields Pharma Inc. is an equal opportunity employer committed to diversity and inclusion for everyone. We are continuously looking for smart-minded, skilled, qualified, experienced, independent, reliable, and detail-oriented candidates to join our successful team.

Our people are at the heart of everything we do.

You can count on;

• Safety as our first core value,
• Integrity,
• Accountability, and
• Continuous Training and skill development.

Reports To: Chief Scientific Officer and Laboratory Manager

Job Description:

The Senior Laboratory R&D and QC Analyst supports both R&D and Quality Control analytical activities at Shields Pharma laboratory.

The Senior Laboratory R&D and QC Analyst is responsible for conducting method development and validation, method transfer, assay and impurity analysis by utilizing HPLC, LC/MS, UPLC, GC-Headspace, GC/MS, ICP-MS, and Dissolution instrumentation according to the schedule established by following the procedures and adhering to Good Manufacturing Practices (GMP), GXP, and good laboratory practices.

The successful candidate will be working in a very fast paced environment, performing both R&D and QC analysis of assigned raw materials, in-process, and final products as per established methods, current pharmacopoeias (e.g. USP, BP, EP, etc.), and the client’s methods and specifications within standard time-lines, and under minimal guidance/supervision.

This position relies heavily on comprehensive wet chemistry and strong chromatographic skills and competencies.

Duties shall include but are not limited to the following:

• Perform all works in accordance with all established company policies, protocols and procedures, and governing regulatory, GMP compliance, and safety guidelines.
• Perform assay and impurities method development, method validation, method transfer, cleaning validation, and stability testing.
• Maintain accurate documentation including lab reports, records of procedures, results, and data analysis in accordance with Good Documentation Practices (GDP) guidelines
• Maintain professional relationship with Internal/External Customers
• Provide scientific advice and training to junior analysts on laboratory instrumentation and methods.
• Perform peer review of analytical reports and data when requested.
• Document and report results in accordance with GMP and GLP
• Conduct Laboratory Investigation (OOS, OOT, Deviation, etc.).
• Provide technical support to other analysts when required
• Collaborate with cross-functional teams to support R&D projects.
• Ensure all general lab supplies (chemicals/non-chemicals) are available at all time.
• Ensure the laboratory is clean in an orderly manner at all time.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all analysts documentation including lab reports, records of procedures, results, and data analysis are accurate and in accordance with Good Documentation Practices (GDP) guidelines.
• Provide oversight of external vendors who are delegated responsibilities when requested.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all generated documentation including lab reports, records of procedures, results, and data analysis are accurate and correct.

Job Requirements: (Work Status, Qualification, Knowledge, and Experience)

• Must possess Permanent Canadian residency with work permit and/or Canadian citizenship.
• Must be living in Canada, preferably in Toronto area
• Minimum M.Sc. (min. 3 yrs. industry experience), or B.Sc. (min. 5 yrs. industry experience), preferably in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines.
• Must have worked minimum of 5 years (depending on the qualification) in pharmaceutical laboratory discipline.
• Must demonstrate solid technical knowledge and extensive expertise on operation, Qualification, trouble-shooting, and maintenance of sophisticated laboratory instrumentation and equipment including, LC/MS, UPLC, HPLC, GC-Headspace, GC/MS, ICP-MS, and dissolution.
• Must demonstrate expertise in analytical; method development, method validation, investigational studies, method transfer, stability studies, and preparation and execution of protocols,
• Should be well versed in understanding of USP, BP, EP, and JP, methods and specifications.
• Must have in-depth knowledge and competency in cGMP/GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), GXP, FDA CFR 211, ICH, and ALCOLA+ regulation and quality system guidelines.
• Should be able to conduct laboratory investigation and other quality attributes (e.g. SOP development, Change Control, Deviation, Root Cause investigation and analysis, CAPA, TAR, etc.)
• Proficiency to MS office (Excel, Word, PowerPoint) is a must
• Track record of multi-tasking, being detail-oriented, trouble-shooting/problem solving abilities, working in a fast-paced environment with minimal instruction on routine work and moderate instruction on new assignments.
• Be punctual, team player, fast learner, and have strong Interpersonal and communication skills,

How To Apply:

Please reference “Senior QC Laboratory Analyst” in subject line and submit resume with cover letter to hr@shieldspharma.com

We welcome and encourage applications from all qualified applicants. We are committed to adhering to our company objectives and requirements outlined above. Kindly refrain from applying if you are not qualified.

We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.

No phone calls please.

About Shields Pharma Inc.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

We offer Laboratory R&D and QC testing services as well as production and formulation of certain psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD, and problematic substance. 

Shields Pharma Inc. is an equal opportunity employer committed to diversity and inclusion for everyone. We are continuously looking for smart-minded, skilled, qualified, experienced, independent, reliable, and detail-oriented candidates to join our successful team.

Our people are at the heart of everything we do. You can count on;

• Safety as it is our first core value,
• Integrity,
• Accountability, and
• Continuous Training and skill development.

We are currently looking for the following  individuals to join our growing team!

Position Title: Metrology Specialist (Full-time)

Reports To: Head of Operation & Laboratory Manager

Job Description:

This is a technical position involving qualification, calibration, preventative maintenance, and repairs of the of laboratory and facility instrumentation and equipment in accordance to Shields Pharma Inc. applicable SOPs and policies, GXP, ICH, GAMP, FDA CFR 211, ALCOLA+ , and other regulatory guidelines and requirements.

Duties and responsibilities include, but are not limited, to the following:

• Performing Shields Pharma instrument and equipment IQ, OQ, PQ qualification and Calibration activities.
• Performing preventive maintenance and troubleshooting of laboratory and facility equipment and instrumentation, and control systems.
• Following company’s written procedures
• Preparing technical SOPs.
• Executing Repairs and accurately documenting repair activities.
• Assessing instrument failures/breakdowns, systematically identifying problems, and restoring to operation
• Review and update calibration procedures based on field experience.
• Supporting, overseeing, and supervising contractors/services providers performing tasks within the company and ensuring the external contractor/s are adhering to the company safety requirements and cGMP standards.
• Identifying opportunities for improving Shields Pharma metrology programs.
• Preparing accurate and comprehensive qualification and calibration protocols and reports in accordance to the company policies, procedures, GDP, and cGMP.
• Completing calibration, PM, and repair documentation accurately and comprehensively including work orders and logbooks in accordance to Shields Pharma policies and procedures, ALCOLA+, FDA CFR 211, and others.
• Ensure equipment/instrument qualifications, calibrations, repairs and maintenance documentations are up-to-date and archived.  
• Create and/or revise calibration and operation procedure/s.
• Support Quality Assurance investigations of instrument failures/breakdowns.
• Perform any other tasks/duties as assigned by departmental management.

Job Requirements (Work Status, Qualification, Knowledge, Skills, and Experience)

• Must possess Permanent Canadian residency with work permit and/or Canadian citizenship.
• Must be living in Canada, preferably in Toronto area
• Minimum Science degree in Chemistry, Analytical Chemistry, Mechanical/electronic Engineering, or similar applied scientific disciplines.
• Minimum of 3 – 4 years of direct and hands-on experience working experience in equipment and instrumentation, qualification, calibration, PM, trouble shooting, and repairs  in pharmaceutical laboratory and production environment.
• Familiar with a variety of hand tools, electric meters, calibration standards to perform essential day-to-day duties.
• Experience working in a Pharmaceutical or similar regulated industry preferred.
• Must be skillful in authoring and executing calibrations, preventative maintenance, repair work where applicable, and other service-related work and documentation.
• Mustdemonstrate solid technical knowledge and extensive expertise on operation, Qualification, trouble-shooting, and maintenance of sophisticated laboratory instrumentation and equipment including, LC/MS, UPLC, HPLC, GC-Headspace, GC/MS, ICP-MS, and dissolution.
• Basic understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters.
• Sound knowledge of Pharmaceutical regulation and guidelines including cGMP, ALCOLA+, FDA CFR 211, GAMP, and NIST as applied to equipment and instrument qualification, calibration and Preventative Maintenance.
• Be able to troubleshoot and repair complex systems and instruments
• Must be focused on problem at hand in a systematic manner and troubleshoot complex systems and instruments.
• Should be able to isolate problem, identify root cause/s, and resolve the issue in a systematic manner.
• Working knowledge of OSHA safe work practices.
• Must be comfortable working with Microsoft Office Applications, including Microsoft Word, and Excel
• Demonstrate  strong people and interpersonal skills including being a team player, problem solver, active listener, easy to work with, etc.
• Must demonstrate clear, concise, and effective communication and written skills when describing technical matters or issues.
• Must be detail-oriented being focused on each project and be able to complete tasks efficiently.
• Should be able to clearly and neatly describe technical issues and be able to document work performed accurately in a technical manner.

How To Apply:

Please reference “Metrology Specialist” in subject line and submit resume with cover letter to mmassoudinia@shieldspharma.com

The information collected to review your application will be processed by the human resources services.

We are committed to adhering to our company objectives and requirements outlined for each position.

We welcome and encourage all applicants for their interest. However, only those applicants that are qualified shall be contacted for interview.

No phone calls please.

Thank You

Kindly refrain from applying if you are not  fully qualified (i.e., work status in Canada, Qualification, Years of Experience, Industry knowledge, and related skills).