Job ref no.: CT3115413-01#9126

QC Manager

Advance Pharmaceutical Company Limited

RESPONSIBILITIES

  • Manage & supervise chemical and microbiology laboratories and testing instruments including routine operations, maintenance and calibration.
  • Purchase of Laboratory Instruments and related Equipment
  • Review and approve QC GMP documents such as SOPs, Sampling Instruction, Specification, Method of Analysis and qualifications of QC instruments.
  • Ensure test methods are validated and analytical instruments are qualified and their regular calibration.
  • Ensure sampling, testing and retention of starting materials, packaging materials, in-process materials, intermediates and finished products are carried out;
  • Issuance and record keeping of related testing reports.
  • Responsible for the approving or rejecting of starting materials, packaging materials, in-process materials, intermediates and finished products.
  • Ensure materials are re-examined periodically and stability studies are carried out.
  • Ensure quality monitoring of cleaned areas and waters for pharmaceutical uses are carried out.
  • Ensure initial, on-the-job training, continuous training and document training assessment and conclusion of training for QC personnel; adjust the training matrix according to actual requirements.
  • Participate in investigation, testing and sampling of finished product quality related issues.
  • Approve and monitor contract analysis.
  • Ensure smooth operation of QC department and PIC/S GMP requirements are met.
  • Other duties assigned by management.    

Requirements:

Qualification Requirements of QCM

  • Holders of a bachelor's degree in analytical chemistry, biochemistry, biotechnology or relevant pharmaceutical science subject
  • at least 5 years of relevant working experience in GMP pharmaceutical quality control, in which at least 3 years of relevant experience at managerial or supervisory level) in 1 or more pharmaceutical manufacturers.
  • Familiar with test method validation, analytical equipment operations and qualification.
  • Familiar with environmental monitoring of GMP Facilities and testing of pharmaceutical products.
  • Familiar with pharmaceutical microbiological testing and validation.
  • Good Management and training skills
  • Familiar with Microsoft Office Applications
  • Independent with good interpersonal skills
  • Good Command of spoken and written English and Chinese (both Cantonese and Mandarin)

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More job information
Job ref no. CT3115413-01#9126
Salary
  • N/A
Job Function
Industry
Location
  • Tai Po
Employment Term
  • Permanent
  • Full-time
Experience
  • 5 years - 10 years
Career Level
  • Middle management level
Education
  • Degree