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QA Manager

Job Details

Location: Japan
Salary: Negotiable
Job Type: Permanent
Specialization: Pharmaceutical & Medical Device
Reference: BBBH42190_1668736916
No consultant assigned to this job.

QA Manager

Position Summary:

As QA Manager, you will be responsible for ensuring that manufacturing and quality control in local toll manufacturers complies with Japanese GMP requirements and IQC Directives from a GQP perspective. You will also be responsible for contributing to the improvement of product quality and safety.

Good Quality Practices (GQP) activities is a unique system defined in Japanese PAL. GQP activities are necessary to ensure the appropriate management of quality for products & systems as MAH.

It includes document management (SOPs, records…), supplier/manufacturer management, batch release for the market, risk management for quality events, and any other relevant activities.

Position Responsibilities:

  • Audit of sub-contractors and suppliers: participation in 3 audits at least to be a qualified auditor.
  • Control of maintenance of Quality Agreement to 100% completion.
  • Management of GQP activities / documents & SOP, batch release, deviation etc all performed promptly.
  • Support on development products and project products performed to maintain schedules and timeframes.
  • Support on product and process improvement for sub-contractors and suppliers along with trouble shooting on the site with the goal of improving the product and stable supply.
  • Support of requested audit from other Sanofi sites.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Knowledge/ Skills Requirements:

  • GQP
  • GMP
  • GDP
  • Negotiation and good communication skills
  • Regulatory (desirable but not essential)

Formal Education and/or Experience Required:

  • Education/training regarding GQP, GMP and GDP.
  • Experience of QA for at least 5 years and more.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

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