QA Packaging Operations Specialist

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Mission

QA Packaging 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 record review and finished product release.
• Manage, evaluate deviations on batch product, drive investigations plan and related corrective action, make a final decision of batch product.
• 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.
• Carry out housekeeping in production area.
• Approval of master batch records, master data and packaging instructions.
• Lead and Follow up of QA KPI on daily meeting.
• To support health inspection and customer audits.

Required Experience & Competences :

• Experience (minimum 2 years) in the pharmaceutical industry
• Scientific background / 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

Location:Switzerland SMP - St Prex