QA Senior Specialist
vor 24 Stunden
For our pharmaceutical partner, Gi Life Sciences is looking for a:
QA Senior Specialist
(Temporary position - 1 year)
Your mission:
- QA vendor oversight activities including the review of commercial bulk and finished drug products, deviation, complaint, and change control record management.
Your responsibilities:
- Manage contractor quality assurance activities to ensure products are manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements.
- Lead discussions with the contractor on quality-related topics, such as complaints, change control, deviations, Out of Specification (OOS) records, processes, methods, procedures, and documentation.
- Recommend quality-related improvements to the contractor.
- Oversee completion of contractor quality-related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
- Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.
- Manage change control requests.
- Process product complaints.
- Review, edit, negotiate improvements to, and approve contractor documentation (process and transfer validation protocol, investigation, deviation, etc.).
- Lead review of Annual Product Quality Review reports, as necessary. Edit and negotiate improvements to contractor supplied Annual Product Quality Review reports.
- Draft or review, negotiate with contractors, and recommend approval for Quality Agreements.
- Participate in self-inspections as appropriate.
- Participate in external audits of contractor manufacturers and distributors as assigned.
Your profile:
- BSc or equivalent in scientific discipline.
- Min. 5 years' experience in QA in the pharmaceutical industry.
- Direct experience interacting with FDA and/or EMEA.
- Experience interacting with external manufacturers.
- Language: English and French, German a plus.
Associate
Employment typeTemporary
Job functionQuality Assurance
IndustriesPharmaceutical Manufacturing
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