Responsible for managing and setting the direction of the QA/QC Laboratory operations (Microbiology, Chemistry, Incoming Inspection) in a GMP/GLP environment.
Recommend best practices to maintain and improve project outcomes or laboratory functions; facilitate laboratory improvement activities.
Analyze data, identify trends, monitor prevention and correction of quality deviations, and develop reports for management utilizing technical knowledge and laboratory experience.
Responsible for sterilization process (Gamma radiation and ethylene oxide) and implementation of sterility assurance program.
Authorize to perform sterilization release.
Verify purchase requisitions, staff leave application, claims and any documentations or paper works pertaining to issues related to laboratory management.
Involves in CAPA and NCR investigation to achieved planned results and opportunities for improvements.
Excellent understanding of ISO13485.
Support QMS implementation through conducting both internal and external quality audit.
Experience in sterilization is a MUST
Requirements:
Minimum Bachelor’s Degree in Life Sciences (Biotechnology, Biomedical, Biology, Chemistry, Microbiology, Biochemistry or equivalent).
Preferably 10 years working experience in laboratory (microbiology, chemistry, or any life sciences laboratory) in medical/pharmaceutical industry.
Certified ISO13485 Lead Auditor is an added advantage.
Good written and spoken in Bahasa Malaysia and English.
Knowledge of laboratory management (GLP), ISO13485, MDD/MDR, FDA or other standard/regulatory requirement related to medical device industry.
Able to act independently to carry out tasks given by management in the time allotted.
