QA Senior Specialist

Vor 4 Tagen

Neuenburg, Schweiz Pouly Tradition Vollzeit

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
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