What you'll do
- Perform QA review for validation related to product transfer and clinical batches
- Provide QA support to validation activities performed in a project
- Take the responsibility for QA in validation activities
- Provide a compliance expertise in Validation
- Acts with colleagues of TRD and production team, and Primary / Secondary Quality Assurance Team (commercial site, TRD) to ensure product transfers are in line with business objectives to meet customer needs.
- Manages quality assurance activities in the Product Transfer Process as part of the network through the application of key business and GMP processes in line with the strategies, policies and standards.
- Approve the relevant validation strategy from phase I to the commercial operation (commercial consistency lots)
- Approve the respect of validation evidence in the process development value stream (PDVS) concept.
- Verified the alignment of the validation from TRD early phases to commercial operation
- Review product/process validation items to assure that deviation from plans and any others issues are proactively identify and correctly solved
- Approve the link between the FMEA and the different risk assessments (TRA, PRA) and their corresponding validation documents.
- Approve the Validation plans.
Who we're looking for
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
- Experience in product and process validation 2 years minimum
- Technical knowledge in pharmaceutical industry (equipment, processes)
- Good oral and written communication skills in French & English
- Problem solving and achievement oriented
- Good interpersonal relationship skills
- At least 5 years of experience in Production, Validation or QA in a biopharmaceutical industry
What you'll get
Our Pharma & Life Sciences department is growing. We offer you the opportunity to join our dynamic team of consultants, work on projects that will challenge you, and that will push you towards the next step of your career.