Job Description
THE OPPORTUNITY
- Opportunity to be a part of the Quality team in Singapore!
- Based in Singapore , the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on The Straits Times and Statista’s list of Best Employers in Singapore for three consecutive years (2021, 2022, 2023).
- Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.
Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
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
Current Contingent Workers apply
Not Applicable
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
Job Posting End Date:09/05/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.