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Interim Head of Quality

  • Location: Hamburg
  • Salary: Negotiable per hour
  • Job Type:Contract

Posted 18 days ago

  • Sector: Pharmaceutical
  • Contact: Eric Bolender
  • Contact Email: e.bolender@sciproglobal.de
  • Duration: 6 Monate +
  • Start Date: ab Januar 2022
  • Expiry Date: 09 December 2021
  • Job Ref: QF_2021_12_1636472561

Projektdetails:

  • Review and approval of GMP QMS submissions
  • Commercial complaint coordinator
  • Lead in the further development of QA and GxP compliance programs and infrastructure, including Policy/SOP development, change control processes, deviation review and investigations, and corrective action and preventative action
  • QA Compliance lead investigator for quality events, complaints, deviations and associated CAPA
  • Escalate quality events to management resulting from external or internal deviations, investigations, complaints, or any other internal compliance related issues
  • Prepare reports to communicate outcomes of QA activities
  • Coordinate and participate in the quality metrics program to ensure timeliness and effectiveness of QMS submissions, and to coordinate GMP quality metrics for Quality Council and management review
  • Lead, support and ensure state of readiness for inspection by regulatory agencies
  • Coordinate any cGMP compliance and/or regulatory updates on behalf of the company