Quality Control (QC) Microbiology, is part of our Manufacturing Division, where we ensure that safe and efficacious medicines and consumer healthcare products are delivered to patients around the world every day through accurate and reliable testing services.
WHAT YOU WILL DO
This position reports to the Manager in the Microbiology Laboratory of API/ Biotechnology Facility. Candidate's main responsibilities are as follows:
- Support testing/monitoring functions pertaining to aseptic manufacturing, plant validation activities.
- Perform routine/non-routine quality monitoring, sampling and testing of utility systems, inclusive of Purified Water, Water for Injection, Pure Steam, Compressed air and Nitrogen systems, for plants, facilities, clean rooms, hygienic areas and labs.
- Perform personnel qualification and re-qualification, lead qualification of clean rooms when necessary.
- Support microbiological testing of Raw materials, Excipient, In-process materials, semi finished products and drug substances manufactured in site-wide facilities. E.g. Sterility test, Bioburden test, Endotoxin test, Microbial Limits Test.
- Perform Method Validation/Suitability/Transfers for drug substances and other drug products.
- Perform Quality Control checks on ready-to-use cultures and maintenance of cell cultures, media receival, sterility check and growth promotion test.
- Perform microbial identification in water, environment and product samples.
- -Review test reports, e- logs, data sheets that are generated in microbiology lab, review compendial and corporate policy changes, analytical specification changes.
- Perform periodic reviews/revisions of e-logs, standard operating procedures, drafting of test protocols.
- Participate in audits, cGMP and all other compliance-related activities, where applicable.
- Support qualification and validation of lab equipment, liaise with external vendors on instrument calibration and maintenance.
- Work planning, scheduling activities.
- Any other tasks as assigned by the Manager.
WHAT YOU MUST HAVE
- Bachelor's Degree of Science in Lifesciences or related field
- 5 to 8 years of relevant experience
- An excellent team player who is meticulous, willing to learn and able to work independently. Has good working attitude.
- Effective communication and presentation skills
- Proficient in IT e.g. Microsoft office
- Good critical thinking and problem-solving skills.
- Basic cGMP knowledge and professional behavior is a must.
WHAT YOU CAN EXPECT
- Limitless opportunities across various areas in Manufacturing; well-structured career path
- A state-of-the-art facility that delivers solution to its customers world-wide
