QA Senior Specialist

For our pharmaceutical partner, we are looking for a:

QA senior specialist

(temporary position)

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 product is manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements

- Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, Out of Specification (OOS) records, processes, methods, procedures, documentation

- Recommending quality related improvements to the contractor

- Overseeing 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...)

- 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 a pharmaceutical industry

- Direct experience interacting with FDA and/or EMEA

- Experience interacting with external manufacturers

- Language: English and French, German a plus

Your contact at Gi:

Manon Tenaud & Anais Mieszczak

022 737 12 07 & 022 737 12 05