- Support testing/ monitoring functions pertaining to aseptic manufacturing and microbiological testing of Raw materials, Excipient, In-process materials, semi finished and finished products manufactured in the API, DPI, Biotech, Tablets and R&D facilities.
- Responsible for testing of developmental and clinical products as required.
- Participate in analytical developmental activities as required.
- 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.
- Perform the routine/non-routine environmental monitoring for all required plants, facilities, clean rooms, hygienic areas and labs, inclusive of particle monitoring test.
- Perform personnel qualification and re-qualification and also to lead qualification and re-qualification of the clean rooms, when necessary.
- Provide testing support to plant validation activities
- Perform in-process and release samples testing of excipient/ packaging components for the different drug products, semi finished drug product and drug substances. i.e., Sterility test, Bacterial endotoxin test, Bioburden test, Microbial Limits Test, etc., as appropriate.
- Perform routine and Batch related Environmental monitoring in clean rooms and other production areas and laboratory.
- Perform Media Receival, Sterility check and Growth Promotion Tests for media used for testing.
- Perform initial Quality Control check and regular QC checks on ready-to-use cultures and maintenance of cell cultures.
- Perform microbial identification (Bacteria, mold and yeast) in water, environment and product samples.
- Perform periodic review of closed out Validation Document packages and Standard Operating Procedures.
- Extend documentation support to the department by participating in writing/revising of SOPs, protocols, Test reports and any other work assigned by the Senior, Lead Microbiologist, Sr/ Manager, Microbiology.
- Liaise with external vendors on instrument calibration and maintenance.
- Solicit quotations of laboratory consumables.
- Maintain continuous supply of laboratory consumables
- Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable.
- Supervise and oversee Third Party Contractors, where applicable.
- Need to co-ordinate with Quality, respective Plant Operations, Projects and Engineering & Maintenance.
- Liaise with other department for training needs and technical support
- Liaise with vendor and service engineers/ESPs for equipment validation, calibration and maintenance work.
- Need to coordinate with suppliers of microbiological media and other equipment.
- Perform method transfers/Qualifications for drug substances and other drug products.
- Maintain the Calibration and Preventive Maintenance Programme.
- Review of compendial and corporate policy changes.
- Prepare trend Reports.
- Perform Qualification and validation of equipment.
- Review and approve test reports log books, data sheets that are generated in microbiology lab.
- Review SOPs and Protocols with relevant to Microbiology.
- Degree in Microbiology / Biotechnology.
- 4 – 6 years’ experience in pharmaceutical industry is preferred.
- Previous OJT is preferred
- Good understanding of Safety and cGMP practices
- Computer Literacy
- The experience in operating laboratory equipment and lab computer systems is very desirable.
- Good oral and written communication skills.
- Analytical development mindset in research and commercialization activities
Job: Quality Lab Related Job Title:Spclst, Quality Control
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Microbiology, Biotech, Engineer, Pharmaceutical, Science, Engineering, Research