Zenith Technologies are looking for a Senior CSV Engineer to join a Global Pharmaceutical based in Southwestern France near Bordeaux for an initial 6-month contract.
The successful candidate should have a strong Pharma/Bio background with hands on experience in Data Integrity reviews and subsequent Remediation activities of site systems and processes. He/she should be highly motivated, an innovative thinker and self-starter, with excellent interpersonal and problem-solving skills.
- Manage, co-ordinate, develop and execute the validation deliverables for new Information System (IS) projects. Support and co-ordinate the qualification and validation processes.
- Ensure that all computer-based systems are operating as intended and meet regulatory requirements.
- Perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) specifically associated with Computer Systems Validations & Data Integrity and as developed and defined in project agreements
- Support activities include but are not limited to; the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change controls.
- Responsible for ensuring that computerized systems are in full compliance with regulatory requirements, company policies and procedures. This individual will provide compliance leadership, direction and execution in Computer System Validation for new projects
- Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.) Participate in required project teams.
- Responsible for ensuring that the Process Development Manager is consulted on all validation deliverables
- Conduct validation training with project team communicating deliverables, procedures and methods.
- A minimum of a bachelor's degree with a minimum of 3 years of related CSV industry experience (Pharma/Biotech)
- 7+ years Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
- Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required.
- Strong knowledge of computerized system development life cycle approach is required.
- The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required.
- Strong leadership skills and the ability to work in cross-functional team environments, as well as independently
- Excellent PC skills with proficiency in automation systems.
- Experience of coordination of Quality documentation and in particular, qualification/Validation documentation.
- Strong written and verbal communication skills are required.