Quality Assurance Manager
Ho Chi Minh City
Degree in Pharmacy / Life Science
5 years in the pharmaceutical industry in Quality Assurance
Registered pharmacist (if applicable)
Good at English
Ensure effective operational implementation of the QMS across all GxP areas
Ensure appropriate functional QMS elements are in place and described in the local Quality Manual/Standard Operating Procedures
Ensure GxP compliance is visible to CP and Area by active liaison with GxP Quality Leads
Report GxP compliance status to CP and Local Leadership Team through the MC Management Review meeting and assure that gaps are addressed appropriately in order to mitigate risk
Ensuring the GxP area(s) under respective Quality unit responsibility are run in accordance with external regulations
Ensuring appropriate levels of resource to complete GCP, GVP, GRP or GMP/GDP activities appropriately
Together with Local Leadership members, ensure conduct of adequate training at the MC in the related GxP activities by defining, planning and supporting training activities. Ensuring GxP self-assessments in the corresponding GxP area
Manage external inspections, complaints, deviations, recalls, counterfeits and product tampering according to the Company Quality Policies and Standards. Ensure relevant CAPAs have been completed / closed
Establishing improvement priorities
Ensure quality oversight of third party and coordinate all required activities to guarantee that third party (re-)packaging, (re-)labelling, storage and/or distribution of Company products is in compliance with Company Standards.
Establishing and maintaining business continuity plans in the corresponding GxP area
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Pharmaceutical
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QA / QC
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Location:
Ho Chi Minh City
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