Quality Assurance Supervisor
Global research-based pharmaceutical and healthcare company with a mission to improve the quality of human life by enabling people to do more, feel better and live longer.
Ho Chi Minh City
Job description
KRA 1. Formulation of directions & business strategies/objectives
Control quality activities at distribution as QMS guideline & monitor the follow of local regulation (GMP/GSP/GDP guideline)
KRA 2: Functional operations management
QMS (Quality management system)
Supervise key elements of GQPs/GQMPs relating to distribution operations and focus monitoring quality risk if occurs.
Implement QMS self-inspection L1 related appropriate activities
Product Quality
Technical Term of Supply and Quality agreement coordination between the local market and supply manufcturing site.
To control quality in receipt, storage, distribution followed with Global Quality Policies (GQPs), with Good Manufacturing Practice (GMP) and local regulatory requirements.
To monitor local redressing/ repacking process and manage repacking activities at local distributors
Control artwork of redressing materials consistency with registration.
To handle quality deviation at third party – distribution and warehouse as well as coordinate with QA Director to solve out the issues (both Cold chain and non-cold chain)
Participate to develop local company quality procedures that affect product quality at third party contractors - distributors
Has authority to approve for release or reject products manufactured by company sites at distributors
Assist QA Director in liaise supply sites to get DRA and documented once QA approval.
Witness the goods destruction at 3rd party contractor
Validate the quality of returned goods as site visit regularly
To control product release at distribution followed with Global Quality Policies
KRA 3: Financial & budget management
Submit and get approval from QA Director any Opex in reference to quality activities at distribution
KRA 4: People management
Deliver QMS training and mandatory quality policies to all distributors’ employees as backup for QA Director
KRA 5: Risk/ compliance management
To provide local SOPs or guidance to distributors
To implement and follow-up Product Quality Risk Assessment through supply chain.
KRA 6. Information Management
Information exchange within function in transparency and open communication.
KRA 7. Internal/External Customer & Partners Satisfaction
Build network with all cross-functional managers in order to build a transparent and consistent working environment within the company..
General requirement
Degree in Pharmacy or Biotech / Pharmacist
5 years working in quality function in Commercial site
2 years working in quality function in manufacturing site
Fluently in English (both Writing and Speaking skills)
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Company Size:
Industry:
Pharmaceutical
Job Category:
QA / QC
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Location:
Ho Chi Minh City
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