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Quality Control Manager, Abbott Healthcare Vietnam

Abbott · Bình Dương
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Type
Full-time
Work mode
On-site
Level
Manager
Industry
Manufacturing
Salary
Thương lượng
Location
Bình Dương, Bình Dương, Bình Dương

Overview

  • 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.
  • 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:
  • 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.
  • 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.
  • 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…

Benefits

Training

Summary of facts from the official posting. View original ↗

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