QA Manager

Key Responsibilities:

• Maintains the Quality Management Manual and implementation of all requirements of the Quality Management Manual.

• Plan, implement, monitor and control company’s procedures and processes.

• Conduct gap analysis, impact assessments and implement any updates from QMS deployment.

• Management of quality documentation, including creation, review or approval of documentation with GSP, GDP and part of GMP impact and record retention and archival.

• Serve as training coordinator to establish the training profiles of employees and ensure the training must be processed. Monitor quality training and personnel qualification programs.

• Lead management of monitoring program and follow-up of corrective and preventive actions programs.

• Supervise and monitor the CAPA from GSK audit to ensure CAPA closure on time.

• Perform & support gap analysis and risk assessments on processes and evaluate compliance to relevant GSP and part of GMP regulations/guidelines & implement/support the implementation of corrective actions.

• Responsible for the review, approval and record keeping of Quality Systems records: CAPA, Complaints, Deviation, Change control, Documentation etc...

• Handle customer complaints and counterfeit in the market.

• Perform the review and approval of Quality Agreement and liaison with manufacturing sites and External Supply Quality to ensure compliance to local registered technical details.

• Assist QA Director organizing Quality council and Risk management review.

• Assist QA Director organizing Local Incident Committee and Product recall.

• Organize to perform Product recall simulation.

• Take responsibility to monitor, assess, and communicate for new or revised Vietnam regulations including GMP, GSP/ GDP, Quality Regulations Intelligence (QRI) and Pharmacopoeia Compendia content.

• Review, assess applicable alert or business impacted evaluation (Quality alert or bulletin).

• Responsibility for quality KPI reporting to management team in quality council.

• Review and approve batch release documentation and provide stock disposition. To approve for release or reject products at warehouse by assignment if required.

• Provide final approval on receipt and dispatching or rejection of vaccines or pharmaceutical products which are imported from overseas manufacturers in case the chief pharmacist is not present (due to work or health reasons).

• Provide support in the GSP quality audit and quality due diligence.

• Ensure documents/records complied with regulatory requirements (GSP and part of GMP and Quality Standard Operating Procedures) within the organization.

• Achieve and sustain the state of compliance to ensure deliverance of quality products to the customer.

• Serve as training coordinator to establish the training profiles of employees and ensure the training must be processed. Monitor quality training and personnel qualification programs.

• Internal/External Customer & Partners Satisfaction.

• Build network with cross functions in order to build a transparent and consistent working environment within the company.

• Assist QA Director build quality culture and quality event.

• Contribute to GSK as be the quality ambassador in the field.

• Build network and partnership with local authorities in working on quality matters.

Requirements:

• Pharmaceutical University degree/Bachelor’s degree in Pharmacy.

• Professional experience in MNC for pharmaceutical (General medicines and vaccines and medical device)

• 5-8 years of professional experience in GSP, GDP, GMP Quality management system on general medicines and vaccines in Pharmaceutical/ Healthcare industries, preferably in the capacity of a quality management level.

• Stakeholder management (internal and external): Strong leadership, mentoring, and interpersonal skills with the ability to interact with personnel at all levels.

• Strong organizational and project execution skills, with the ability to effectively manage multiple tasks, priorities, and deadlines in a fast-paced environment.

• Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits

• Knowledge on effective quality documentation systems.

Essential Skills and Abilities:

• English: fluent oral & written communication skills

• Ability to deliver clear communications and good working relationships with peers and management

• Problem-solving skills within a structured process

• Good team player – works well in cross-functional teams

• Works with a spirit of continuous improvement, creatively open to new ideas and methods

• Good general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook

• Proficiency in MS Office / knowledge in SAP or ERP, Documentation system

• Relationship building & networking capability

• Leadership ability

• Good communication & inter-personal skills. Ability to support and challenge at the same time senior leaders