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