Job Detail

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Job Titel

Quality Assurance Operations Specialist

Job Beschreibung

Your mission:

Carry out Quality report investigations and closure, in order to allow batch record review and potential release by QP, or its delegate, in conformity with the registration dossier and cGMPs Manufacturing Batch record review.

Main Responsibilities :

• Ensure GMP compliance for production and QC activities according GMP compliance requirements


• 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 for production and QC activities (including anomaly, OOT and OOS) on batch product, and drive investigations plan and corrective action. Decide about batches affected by deviation when appropriate.


• Escalate according internal SOP, any remaining gap versus internal specifications, registration dossier and cGMPs


• Ensure GMP compliance, especially during reprocessing activities. Approve relevant protocol prior execution


• Handle  finished product drug complaints related to defect linked to the Manufacturing process


• Write APR (Annual Product review) / PQR (Product quality review) according to annual Master plan defined


• Follow up CAPA and change control for production and QC 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


• Review and Approval of master batch records, procedure, master data and stability protocols or reports


• To support health inspection and customer audits

Required Experience & Competences :

• Scientific background with 3-5 years of relevant experience in Quality Assurance/Quality Control in a Pharmaceutical company


• Good communication in French and English


• Strong understanding of cGMPs and good knowledge in Regulatory and compliance requirements


• Good knowledge in QC technologies and solid dosage form


• Good communication and interpersonal skills


• Problem solving mindset


• Team spirit, flexible, customer and result-oriented


• Ability to take decisions and work independently

Ort

Switzerland SMP - St Prex