PIC/S GMP laboratory authorized personnel; build up and ensure the whole quality system meets GMP requirement; the key personnel for product release for sales in GMP system.

Job Responsibilities:

• Manage the quality of contract cell production laboratories to ensure laboratory infrastructure, environmental control, equipment, processes flow and products to meet PIC/S GMP requirements;
• Ensure the safety and suitability of manufacturing and quality control procedures;
• Ensure that validation is performed according to GMP requirements;
• Ensure that document control includes the establishment, updating and regular management of operational processes in accordance with GMP requirements;
• To assist internal audit, external audit, government license approval, quality agency accreditation;
  
• Perform a product batch review and verify that the batch meets the requirements for its clinical trial authorization or sales authorization;
• Coordinate and enforce supplier qualifications and audits, and self-check;
• Lead, manage and ensure the training of BioCell staff on quality assurance procedures and regulatory guidance.

Job Requirements:

• Bachelor Degree or above ;
• 7 years working experiences;
• Good command of written and spoken English, Mandarin and Cantonese;
• Experience in PIC/S GMP
• Sterile manufacturing experience is preferred
• Registered pharmacist 

We are a subsidiary company of a listed company (“the Company”), which is principally engaged in research and development of bio-medical and healthcare products, and medical techniques; the provision of the production and sales of tissue engineering products and its related derivatives; as well as sales and distribution of medical products and equipment. As a pioneer of biological tissue engineering and the industrialisation of regenerative medicine in the PRC, the Company focuses in four major core areas, namely cellular and stem cell therapy; tissue engineering; cosmetics and healthcare; and medical equipment and other services. To cope with our recent expansion, we are inviting high caliber and experienced candidate to take up the following position: