Tuyển dụng Quality Control Manager, Abbott Healthcare Vietnam tại Bình Dương

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…

Yêu cầu công việc

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

Quyền lợi

• Thưởng: 13-month salary & performance bonus
• Chăm sóc sức khoẻ: Premium Healthcare
• Đào tạo: Training & Development