QA Specialist

St.-Prex, Switzerland

Posted: 4-Oct-2018

Ref#: CH-FER-0094 / R0003769


Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.

In our Headquarter in St-Prex/Lausanne (Switzerland), we are looking for an:

                Quality Assurance Operations Specialist

Your mission:
QA Operations Specialist ensure that batch records are reviewed in a timely manner according to all SOPs, carry out Quality reports investigations and closure, in order batches could be released by QP, or its delegate, in conformity with the registration dossier and cGMPs.

Main responsibilities:

  • Ensure GMP compliance for production activities
  • Production batch review in order to assess the quality of the batch (perform random check at the lines during production activities)
  • Change status of component if appropriate to ensure GMP rules. Reject boxes or batches when appropriate
  • Manage, evaluate deviations on batch product, and drive investigations plan and corrective action. Decide about batches affected by deviation when appropriate
  • Ensure GMP compliance, especially during reprocessing activities. Approve relevant protocol prior execution
  • Handle  finished product drug complaints related to defect linked to the packaging process
  • Write APR (Annual Product Review) / PQR (Product Quality Review) according to annual Master plan defined
  • Follow up CAPA and change control for production activities
  • Ensure feasibility of current SOP for QA operations activities and update as appropriate timeline
  • Ensure validity of equipment used for production activities based on qualification status defined
  • Approval of master batch records, master data and packaging instructions
  • To support health inspection and customer audits

Required Experience & Competences:

  • Scientific background
  • Experience in the pharmaceutical industry
  • Experience in QA department
  • Good communication in French and English
  • Strong understanding of cGMPs and good knowledge in Regulatory requirements
  • Good communication and interpersonal skills
  • Problem solving mindset
  • Team spirit, flexible, customer and result-oriented
  • Ability to take decisions and work independently

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