JOB DESCRIPTION

Duties:

• Serve as the registered Authorised Person (AP) and primary guardian of product quality and regulatory integrity.
• Lead the Quality Control department in a PIC/S GMP environment to ensure full compliance with Hong Kong’s Pharmacy and Poisons Regulations (Cap. 138A).
• Personally authorize the release of each batch of finished pharmaceutical products for sale or distribution.
• Certify that every batch complies with registered particulars and current GMP guidelines issued by the Pharmacy and Poisons Board.
• Proactively manage the maintenance and renewal of all essential corporate and manufacturing licenses.
• Act as the primary liaison for the Department of Health, overseeing regulatory inspections and product recall procedures.
• Review and approve all QMS documentation to ensure technical accuracy and legal compliance.
• Manage daily QC laboratory routines, including method development, validation, and equipment calibration.
• Oversee the drafting and implementation of Standard Operating Procedures (SOPs).
• Provide the management team with training and updates on new regulatory, legal, and compliance requirements.

Requirements:

• Degree in a Science or Engineering discipline.
• Minimum 3 years of managerial or supervisory experience in manufacturing or QC within a PIC/S GMP environment.
• Must meet the requirements to be registered as an Authorised Person (AP) with the Pharmacy and Poisons Board of Hong Kong.
• Expert-level understanding of Cap. 138A, ISO/IEC 17025, and international GMP standards.
• Strong command of English and Chinese for effective communication and regulatory reporting.

Please send in your full resume with last drawn, expected salary and availability to Bond West Application Email Address : [email protected] or via “APPLY” button.