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QA Manufacturing Operations Manager

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QA Manufacturing Operations Manager

Job Title:

QA Manufacturing Operations Manager

Job Description:

Mission:

Lead QA Operations manufacturing team in order to achieve defined goals in terms of GMP compliance review, deviation handling and release. Interact with operational departments and managers in order to maintain GMP status of activities, and develop their robustness. Ensure proper KPI/KQI are available to the Senior QA Manager/QP in order to allow good anticipation on organizational decisions.

QA Operations Manufacturing Manager is expected to be QP delegate.The role will work with team members across functions, both internal and external.

 

Main Responsibilities:

  • Ensure operational documentation (SOP, MBR, Instruction...) are conform to GMP and CTD requirements
  • Ensure availability of approved batch record documentation for production
  • Ensure release process for incoming and in-house bulks
  • Review of deviations and batch confirmation/certification
  • Organize the team in order to perform in due time the approvals of master datas linked to product recipes (recipe and associated validity rules in the ERP system, LIMS article, Packaging instruction, Master recipe (eBR)...)
  • Timely follow-up of deviations, CAPAs, CRs and related complaints.
  • Support Customer relations:  Ensure that local requirements from internal and external customers are applied during production and release process. Inform QA customer (internal or external) of quality events when needed
  • Write annual product review
  • Review or approbation of SOPs and other documents (incl. Master Batch Record) for above mentionned activities
  • Active participation during HA inspection and customer audits
  • KPIs management of related activities
  • Replace QP during his absence

     

Required Experience & Competences:

  • Pharmacist or University degree in sciences-related field (biologist, chemist) or equivalent with more than 5 years of relevant experience in Quality Assurance / Production in a Pharmaceutical Company,
  • At least 3 year of managerial experience
  • Good knowledge in Regulatory requirements
  • Good knowledge of pharmaceutical manufacturing technologies and analytical QC methods
  • Excellent leadership skills and ability to in?uence and work across organisational boundaries.
  • Good communication skills excellent command of French and English

 

Location:

Switzerland SMP - St Prex

Vaud / Switzerland HQ - St-Prex / Switzerland SMP - St Prex / St-Prex / St Prex

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