Overview
WuXi Biologics is a leading global Contract Development and Manufacturing Organization (CDMO) specializing in biologics. The Singapore site is a greenfield biopharmaceutical start-up project with large-scale Drug Substance (DS) and Drug Product (DP) manufacturing operations, establishing one of the largest biologics production capacities in Singapore.
The Quality function is responsible for ensuring that all products meet regulatory requirements, internal quality standards, and patient safety expectations. The team performs laboratory testing and quality assessments throughout the manufacturing process to verify product quality and compliance.
Working Location : Tuas Biomedical Park. Company shuttle bus is provided at various MRT pick-up locations
Job Responsibility
- Understand GMP and follow instructions on the documents.
- Support lead to create the RM strategies, including but not limited to specification strategy, sampling strategy and testing strategy.
- Create the relevant document (e.g. SOPs/Protocols/Reports/QRAs/AMPs) related to RM and Compendial.
- Perform incoming materials/Raw material sample sampling and its transporting needs in/between the various building sites in SGTB site or other WuXi Biologics sites (when needed)
- Perform raw materials, compendia related testing including but not limited to pH, Osmolality, Titration, HPLC, GC, Raman, IR, Sub-visible particles, visible particles, weight variation, colour, clarity etc. Able to analysis and report results independently and in a timely manner.
- Execute lab procedures according to and in compliance with cGMP guidelines and internal SOPs.
- Support lead to establish the method verification/qualification/validation strategy.
- Create the method verification/qualification/validation protocol as per established strategy.
- Execute the method verification/qualification/validation as per the relevant protocols and generate corresponding reports.
- Management of raw material samples, raw material sampling room, sample storage room and regulatory retain sample room, etc., and ensuring the sampling process and storage of raw material samples are under conducted properly and within control.
- Support reagents/consumables inventory/invoices management to ensure consistent QC RM/Compendia operation needs.
- Ensure that all data from the laboratory is in accordance with good GDP practices to ensure data integrity.
- Ensure compliance with training, preparation, documentation and general lab maintenance requirements for Industry Standards and/or Regulations.
- Optimize methods to improve efficiency while adhering to Quality Control standards.
- Troubleshoot any issues on assays, instrument, or reagents.
- Investigate any OOS/OOT and atypical results and laboratory investigations, conduct root cause analysis, and implement CAPA.
- Conduct the Quality Events, such as Change Control, Deviations, and CAPA, etc.
- Attend internal and external meetings and present data summary, investigation results, or trending analysis to project teams or clients.
- Proactively respond to and participate in scheduled audits and able to defend methodologies to auditors.
- Any other duties assigned by the lead.
Other requirements
- Extensive experience in Raw Material (RM) related assays, compendial assays, including but not limited to pH, Osmolality, Titration, HPLC, GC, Raman, IR, sub-visible particles, visible particles, weight variation, colour, clarity etc.
- Knowledge of pharmacopoeia for incoming materials/Raw material (RM) specification generation, and for the Drug Substance (DS)/ Drug Product (DP) compendial methods generation.
- Experience and understanding Incoming materials regulations and guidelines with in-depth understanding of cGMP.
- Experience in validating and executing RM/compendial testing methods, identification methods, and evaluating new technology or methods.
- Ability to follow GMP guidance and all QC general SOPs.
- Ability to conduct basic troubleshooting, experience with application of root cause analysis tools for investigation execution.
- Experience with Quality Systems (e.g. Document/Quality/Learning management system, Change Control, Deviations, and CAPA programs)
- Ability to adapt between strategic and tactical thinking/planning and provide suggestions to optimize procedures, including but not limited AMP, Protocol, SOP, Report, etc.
- Able to raise issues immediately to supervisor and work with supervisor when doubt.
