Quality Assurance Manager

LP & Associates' client

Ho Chi Minh City

Posted 21 months ago

• JOB REQUIREMENTS

Degree in Pharmacy / Life Science

5 years in the pharmaceutical industry in Quality Assurance

 Registered pharmacist (if applicable)

Good at English

• JOB RESPONSIBILITIES

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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