- Support new equipment qualification, lab computerized systems, and chemistry lab setup.
- Perform transfer, verification, and validation of laboratory procedures.
- Prepare technical documentation, including protocols, analytical write-ups, standard operating procedures, specifications, investigations, and reports.
- Analyze incoming goods, intermediates, and finished products under cGMP conditions for QC release and stability studies.
- Lead the testing process from sampling to the release of raw materials, drug substances, process aids, and packaging materials.
- Ensure timely and compliant testing of all chemistry-related analyses, including HPLC, GC, and stability analysis.
- Manage daily laboratory operations, ensuring compliance with GMP standards.
- Identify and address compliance gaps with updated pharmacopoeia and regulations.
- Lead laboratory investigations, deviations, and ensure timely closure in line with quality management systems.
- Review analytical and laboratory data for accuracy and compliance.
- Perform maintenance and calibrations on laboratory equipment.
- Troubleshoot technical issues related to analytical equipment and methods.
- Manage QC chemical, reference standard, and consumable stock levels.
- Train fellow chemists, serving as a mentor and expert.
- Maintain a detailed understanding of international regulatory requirements.
- Communicate effectively with cross-functional teams and participate in problem-solving activities.
- Act as a Subject Matter Expert during audits and inspections.
- Undertake internal audits and support continuous improvement initiatives.
- Promote a culture of quality and adherence to cGMP, EHS, and 5S standards.
- Be prepared to support shift work if needed.
Minimum Requirements/Qualifications
Education:
- University degree or equivalent experience in chemistry, biochemistry, or life sciences.
Experience:
- At least 7 years of proven experience in the pharmaceutical or medical devices industry, with a focus on Quality Control.
- Extensive knowledge of regulatory expectations including PICS, ICH, Singapore HSA, EMA, and US FDA.
Proficiencies:
- Knowledge and exposure to cGMP environment.
- Sound technical knowledge of QC chemistry techniques (HPLC, UPLC, CE, etc.).
- Strong interpersonal and communication skills in English.
- Ability to work cross-functionally and meet timelines and objectives.
- Experience with Health Agency/internal audits.
