Manager - Quality Operations

Job Description:

 Responsibilities

• Reporting to Zentiva Quality Operations & Compliance Manager, the Quality Operations Specialist will take lead responsibility for Product Quality Reviews (PQR) review completion for the cases in which Zentiva Quality Operations is marketing authorization holder (MAH).
• Responsible to meet the established schedule in completing the reviews of PQRs.
• For each evaluated PQR the Quality Operations Specialist will ensure that the traceability of the evaluation (report) is always available (document crated, approved/signed and properly archived) according to Zentiva Quality Operations procedures.
• Responsible for flagging /escalating to the Zentiva Quality Operations & Compliance Manager any delays on time.
• Prepares trends analysis and KPI on PQR review process.
• Responsible for ensuring the maintenance of a up to date document for tracking of PQRs review operations and will support Zentiva Quality Operations & Compliance Manager in the preparation of periodic reporting of the PQRs review. The tracking document shall permit to Zentiva Quality Operations to identify PQRs evaluated as “to be improved” or which are not meeting the requested quality standards.
• Responsible for calculating PQRs review KPIs on monthly basis.
• Responsible for the extraction and data compilation of analytical, manufacturing (including deviations, complaints, and change requests) from appropriate IT tools (Quality Forward, Share/DrugTrack, eDMS) and regulatory data (HA commitments, variations).
• Responsible for collecting stability data and reports for product-related evaluations. (e.g. compliance investigations, divestitures, product transfers, validation. etc.).
• Responsible for scheduling meetings with the transversal functions in case clarifications are needed or to determine and assign follow-up action items, if required

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Qualification & Expeirence

• Graduated / post-graduate in Pharmacy/Medicine or Chemistry/Biotechnology
• 10 to 14 years minimum experience in Quality or Regulatory Affairs
• Experience obtained in pharmaceutical manufacturing sites (+8 years).
• Knowledge of stability regulations and its application to the industry
• Skilled in the usage of IT tools (for example: Quality Forward, Share/DrugTrack, eDMS), SAP.
• English speaker
• Good organizational skills, stress resistance, and flexibility
• Good Team player and good in decision-making
• Interpretation/Analytical data.
• Experience in the pharmaceutical/biotech industry with a good level of GxP know-how is a strong plus.
• Reactivity, autonomy with a sense of urgency and priorities.
• Open-mindedness and team spirit.