Quality Assurance Officer, Pharmacovigilance
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Responsibilities
- Ensure quality management of PV deviations (RCA, CAPA, process compliance and timelines).
- Identify quality risks and implement appropriate corrective actions.
- Contribute to PV quality documentation and the annual quality plan.
- Support the Quality Management System (QMS) through monitoring of CAPAs, KPIs, deviations and changes.
- Participate in audits/inspections and ensure compliance of partners and suppliers.
Qualifications
- Education: Master’s degree in Life Sciences with a specialization in Quality Assurance/Pharmacovigilance (QA/PV) or Pharmacist.
- Experience: Initial experience in pharmacovigilance (PV) and/or quality assurance (QA) in managing PV deviations — ability to assess the adequacy of root cause analyses (RCA) and proposed CAPA (corrective and preventive action) plans from various stakeholders, and to guide them as needed from a QA/PV perspective.
- Skills: Solution-oriented, ability to work in an international environment, strong interpersonal skills. Proactive in anticipating issues, identifying risks and resolving problems.
- Languages: Excellent written and verbal communication skills in English.
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