QC Manager (Team 2)

Job level Entry
Work exp Minimum 2 Years
Education Doctorate or above
Location
Shatin
Industry Biotechnology / Chemicals / Testing / Laboratory
Job function Manufacturing > Quality Assurance / Control
Quality Control / Quality Assurance > Quality Control & Assurance
Science / Lab / Research > Biotechnology
Published On 15/10/2021

Responsibilities:

  • Reports to GM and lead the QC Team and responsible for management of the Quality Control (QC) team and for performing Cell Biology, Biochemistry, and Safety assays in support of the production, release, and distribution of ATPs as well as maintenance of the Facility.
  • Provides advice to subordinates when determining how to meet schedules and/or resolve technical problems.  Reviews testing and laboratory records for accuracy and compliance with cGMP and HKIB policies and principles. 
  • Monitor QC resource capacity.  Provides feedback to management and production planners when capacity constraints exist.  
  • Develops and monitors team performance measures to understand effectiveness, efficiency, and quality of group performance.
  • Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).  Actively works to ensure responses are completed on-time.  Escalates roadblocks to completion and provides potential solutions. 
  • Ensures that QC processes are validated and all staff are trained to the validated procedures.
  • Informs GM, QM and/or AP of all quality incidents, non-conformances and deviations.
  • Provides QC training to relevant personnel


Requirements:

  • PhD in Life Sciences (Biotechnology, , biomedical engineering, medical laboratory science, and other similar disciplines with at least 2 years of working experience at supervisory level in GMP quality control of Advanced Therapy Products (ATPs) or sterile biologics.
  • Must have experience in aseptic processing, and inspections
  • Strong knowledge of HK and EU pharmaceutical GMPs

 

A competitive salary package commensurate with academic qualifications and experience will be offered. Fringe benefits include paid leave, medical benefits, insurance coverage and contribution to MPF.

Applicants should submit a resume, expected salary and contact number to The Hong Kong Institute of Biotechnology Ltd., 2 Biotechnology Avenue, 12 Miles, Tai Po Road, Shatin, N.T., Hong Kong, or fax to 2603 5012