Total 1 quality assurance job vacancies in Singapore

Microbiology and Biochemical Product Testing:

• Perform EM such as active air sampling, surface and passive air samplings, plate readings and inspection of cleaned facility and sterilised equipment
• Responsible for planning,monitoring and approving microbiological testing
• Perform method Qualification,validation and product testing (e.g. sterility and endoxin) to support QC lot release.
• Perform stability testing of released final products as per protocol and timelines.
• Support assessment of certification/accreditation and services provided by external labs for QC testing.
• Knowledge in biochemical testing, including cell counts, flow cytometry, ELISA, PCR analysis, and compendial testing (pH, Appearance) as per USP, JP, and EP standards

Documents, Records and Data Management:

• Drafting and updating of Standard Operation Procedures (SOPs) and specification documents for EM, equipment, sampling plan, test methods, final products and raw/packaging materials.
• Author and review technical protocols and reports (e.g. EM risk analysis), develop guidelines and standard practices for data documentation, analysis and training.
• Review test results, document data and produce trends (e.g. EM) in an efficient, organised and presentable manner to facilitate discussions, support business and performance metrics reporting.

Deviations, Change Control and Audits Management:

• Support deviations (e.g. test OOS, EM excursion) initiation, investigations and root cause analysis for product defects and quality lapses.
• Support change control and CAPA implementation.
• Support internal and external audits/inspections.

Equipment and Lab Management:

• New equipement commisihing support( Operational qualification-OQ, Performance qualification- PQ
• Monitor and schedule equipment calibration and maintenance as per schedule and site master file.
• Perform lab housekeeping, lab cleaning and biohazard/waste management.
• Perform monitoring and procurement of lab inventory, for e.g. materials and consumables.

Continuous Improvement:

• Implement initiatives to encourage improvement of QC procedures, activities and workflows.
• Conduct routine literature review through established publication channels to ensure continual knowledge proficiency on both GMP and current technological trends relevant to CellVec’s activities.