Quality Assurance Specialist
vor 16 Stunden
We are seeking a Senior Quality Control Professional to join our team at Gi Life Sciences.
The successful candidate will be responsible for managing contractor quality assurance activities to ensure product compliance with regulatory and corporate requirements.
Key Responsibilities:
- Manage vendor oversight activities, including review of commercial bulk and finished drug products.
- Lead discussions with contractors on quality-related topics, such as complaints, change control, deviations, and Out of Specification (OOS) records.
- Recommend quality-related improvements to contractors.
- Oversee completion of contractor quality-related activities, including process, method, and procedural improvements.
- Review batch records, ensuring compliance with GMP and registration requirements.
- Manage change control requests and process product complaints.
- Review, edit, and approve contractor documentation, including process and transfer validation protocols.
- Lead reviews of Annual Product Quality Review reports and draft or review Quality Agreements.
Requirements:
- BSc or equivalent in a scientific discipline.
- Minimum 5 years' experience in QA in the pharmaceutical industry.
- Direct experience interacting with FDA and/or EMEA.
- Experience interacting with external manufacturers.
- Fluency in English; proficiency in French and German is an asset.
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