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)

Interested parties please send CV and expected salary by clicking "Apply Now" for interview.

Data collected will be used for recruitment purpose only.