Quality Control Manager, Abbott Healthcare Viet Nam

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Job Summary:

• Report to: Head of Quality
• Working Location: VSIP 1, 35 Tu Do Boulevard, Vietnam Singapore Industrial Park

ROLES & RESPONSIBILITIES

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…

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED

• At least 2 years working experience at the same position, having experience of pharmaceutical company or manufacturer.
• Understanding the systematic process of WHO-GMP, PIC/S -GMP, EU-GMP, in the pharmaceutical industry.
• Having knowledge in the laboratory.
• Having knowledge and experience in quality control
• Skill of organization and arrangement
• Analytical, problem solving skills
• Ability to use MS office Ability to use English
• Team work and project management skill, communication skills, enable people to result
• Capable leadership

MINIMUM EDUCATION REQUIRED

Minimum Education: Graduated from University of chemistry or pharmacy

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

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SIGNIFICANT WORK ACTIVITIES: