Job Information
Sanofi Group Quality Assurance Manager in Tokyo, Japan
JOB SUMMARY
On the basis of Sanofi quality policy and Japanese regulations, make available to customers high quality products and services through promoting Quality Assurance activities strongly and leading / supporting Japanese Contract Manufacturing Organization in order to ensure quality of pharmaceuticals and cosmetics under the regulatory compliance as a manufacturing and Marketing Authorization Holder (MAH).
Mission of the EMQA:
Ensure that manufacturing and quality control in local Contract Manufacturing Organization comply with Japanese GMP requirements and Sanofi Global Quality Directives from a GQP perspective and contribute to the improvement of product quality and safety.
Objectives:
Good Quality Practices (GQP) activities - GQP is a unique system defined in Japanese regulation.
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.
Support Project management team for implementation of new products.
KNOWLEDGE AND SKILL REQUIREMENTS (Minimum requirements for assignment to this job.)
Knowledge And Skills:
Fluent English communication skills
Daily Japanese communication skills as a minimum
Global regulations (EU, US)
Global requirements / guideline (PIC/S, ICH, WHO, IPEC, ISO 9001, ISO 13485)
Experiences in QA(+QC) area for at least 3-5 years
Good communication skill
agility with Digital tools
Experience of Pharmaceutical environment
Knowledge And Skills Desirable But Not Essential:
Pharmacist
Regulatory (Packaging insert, Label, Artwork etc.)
Japanese regulations (GMP, GQP/GDP, GLP, QMS, Pharmaceutical Low [Pharmaceutical and Medical Device Act])
Chemistry (HSE, SDS, DMF, etc.)
Cross-functional leadership
Self-motivated individual who is comfortable with working independently
Makes effective quality decisions with high sense of urgency
Experience of Vaccines/Biologics, and aseptic operations is a plus
PRINCIPAL DUTIES AND RESPONSIBILITIES
Briefly describe the major duties and responsibilities for which the job is held accountable
MAJOR DUTIES & RESPONSIBILITIES (what the job does)
END RESULTS EXPECTED (why is it done/impact)
1. Deviation Management (incl. CAPA management)
Registration of Deviation in the Database
Ensure the investigation is completed by CMO
Request analysis of sample and expedition if needed
Escalate the investigation to originating site when identified by investigation, and ensure the investigation is completed
Provide investigation conclusion to SAKK Qualified Person for Batch decision
Participate in evaluation of risk and escalate the risk alert when identified
Communicate the decision to CMOs
Monitor the deviation activity and generate monthly KPI for reporting to Global
2. Batch Release and Global Release management
Batch release and monitoring (for CMOs without delegation of release)
Check that the release documentation provided by CMOs is compliant with GQP regulations
Prepare the GQP release form for SAKK Qualified Person
Provide GQP release form to CMOs when decision is made to release the batch on the market
Provide signed Pre-shipment Agreement, under Quarantine request, and any documentation necessary to batch reception to CMOs
Review the temperature excursion data and escalate Deviation in Global database in case of non conformity
Review of Visual Inspection results provided to CMO and escalate Deviation in Global database in case of non conformity
Manage the release document provided by manufacturing site and provide them to CMOs for batch release
3. NIID Testing Coordination
- Coordinate the testing of Sanofi vaccines with the National Institute of Infectious Diseases that are imported to Japan
4. Quality Alert Management
Participate in evaluation of risk and escalate the risk alert when identified (pre and post product release)
Coordinate the management of quality alert locally and report to Global
5. Audit
- Participe the in some of the audit of CMOs as a lead auditor or co auditor as per annual audit plan
6. Support
- Support other Manager within EMQA Japan or divisions (Business Units, Pharmacovigilance, Medical Affairs, External Affairs, Regulatory Affairs, R&D and Supply Chain) with expertized QA approach
7. Promote HSE, People & Culture mentality
- Develop supportive & comfortable working environment
Sanofi Group
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