Quality Control Manager, Abbott Healthcare Vietnam

Primary Job Function
• Build a quality control room according to GMP and GLP rules according to current standards and Establish Pharmaceutical Division of Abbott.
• Resource planning including people, equipment, chemicals, reagents, standards, and other facilities to ensure testing activities meet business needs.
• Optimize the lab operation to support for business sustainability in future.
Core job responsibilities:
• Manage the quality control at site to comply the requirements from Abbott Establishment Pharmaceutical Division with sustainability status.
• Training, personnel management
• QC budget control to ensure all activities of QC have enough resource to implement
Position Accountability/Scope:
1. Manage the quality control at site to comply the requirements from Abbott Establishment Pharmaceutical Division with sustainability status.
• Manage all activities of the physical, chemical and microbiological testing laboratory.
• As per site production plan, assure the analysis performance of raw materials, packaging materials, finished products, water samples ... on-time.
• Review of technical data package. Review/approval of analytical data sheet, equipment calibration and validation protocol and report for drug
• Approval/ Release/ Rejection of test result and CoA.
• Review/approval of quality control document
• Investigation and department approval of deviation, OOS, change control and coordinate with analyst and other depart
• Responsible for overall department activities and approval of documents/protocols.
• Ensure timely application of the compendial update program.
• Ensure the use of validated/verified methods in the testing laboratory
• Supervise the laboratory equipment management program.
• Supervise the chemical-reagent-reference standard management program.
• Assure the on-time stability testing of products.
• Monitoring the sampling, the storage during testing and the retention of materials, packaging, finished products, standard, chemicals, reagents, stability samples and the laboratory environment conditions.
• Participate in product transfer and ensure the test method transfer is carried out according to requirements.
• Responsible to co-ordinate with auditor and compliance the observation within the time frame.
• Join in the annual internal audit as qualified auditor and participate in the issue investigation related to operation and quality system.
• Responsible to maintain the laboratory meeting the applicable current GMP requirement and be readiness for any inspection/ audit.
2. Training, personnel management: Lead the GLP training program.
• Manage, review the training plan establishment and execution of the Quality control department.
• Organize analyst certification.
• Collaboration with regional/ divisional SME to improve the GLP knowledge at site, training the laboratory team about the professional knowledge and audit readiness.
• Responsible for the annual evaluation of the reporting lines.
• Lead the establishment of laboratory performance project scorecard.
• Lead the laboratory productivity improvement year by year.
3. QC budget control to ensure all activities of QC have enough resource to implement.
• Accountable for annual QC budget forecasting, implementation and monitoring.
• Identify, recommend and implement process improvements to enhance testing strategies.
• Co-Lead for key projects delivered from Region and Division as Lean lab, Compete program...