PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of hundreds dedicated consultants, PQE delivers the highest level of expertise to more than 160 customers worldwide. An international group, PQE operates in over forty countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets.
Further information can be found at www.pqegroup.com.
We are currently looking for a Junior Validation Specialist to support our Life Sciences Group projects and our growing business in the US. It is an excellent time to come join our team.
Responsibilities include, but are not limited, to the followings:
- Collaboration in project teams related to GxP Quality AssuranceUtilize IT/IS, vendor, and client specifications to generate and execute testing protocols for computer systems following client procedures and good documentation practices
- Be involved in various roles in the validation process, including the creation and execution of qualification protocols (IQ, OQ, PQ)Assist in deviation root cause analysis and corrective action plans
- Generate final and summary reports for executed test protocols
- Provide technical and compliance input into project execution strategies to ensure regulatory requirements are met.
- Generate and support higher level project documentation as required such as Masterplans, schedules, and summary reports.
- Working in the full range of Biotech/pharma project phase execution including all design phases, construction, startup, CQV, and project hand-over activities
- Maintain a close interaction with Clients and the ability to work and communicate with both team members and external stakeholders
Requirements:
- Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics, Biology, …)
- Interest in becoming a Quality Consultant for the Pharma/MD Industry
- US working visa
- Full Availability to travel domestically (up to 70%)
Nice to have:
- PhD in technical fields
- IT background, passion for Informatics and quality
- Experience in Pharmaceutical Sector
Current Locations: Southwest and East Coast
Full-Time Position
Our collaborators are engaged, developed, challenged and well-rewarded for performance.
We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.