Quality Assurance Supervisor

N.A.TOPJOBS’S CLIENT

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

Posted 74 months ago

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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