We are currently looking for a QC Scientist for a leading player in the Pharmaceutical Manufacturing Industry with a legacy of more than 20 years in the world. This position requires your urgent attention.
- Reporting to: Quality Manager
- Based in Johor
- Attractive remuneration and benefits package
the job
- Perform physical and chemical analyses in compliance with SOPs, cGMP, GLP, and applicable regulatory standards (FDA, DEA, OSHA).
- Utilize advanced understanding of regulatory guidelines and pharmacopeial standards in laboratory practices.
- Carry out and document raw material, in-process, finished product, validation, and stability testing in accordance with approved methods.
- Lead and ensure successful completion of Method Transfer and Method Validation activities within the QC laboratory.
- Conduct comprehensive testing including assays, impurity profiling, content uniformity, identification, LOD, moisture, particle size, and bulk/tapped density.
- Inspect raw materials and issue Certificates of Analysis (COAs) within defined timelines, maintaining accuracy in Oracle-based systems.
- Ensure lab equipment is properly maintained and functional; oversee microbial testing and environmental monitoring in GMP areas.
- Train QC staff, troubleshoot testing issues, review documentation, and ensure adherence to SOPs and industry regulations.
- Author and review COAs and stability reports; ensure compliance with ISO 9001, safety protocols, and internal quality systems.
- Participate in special projects, lean initiatives, and process enhancements across QC, logistics, and supply chain functions, while fulfilling other assigned duties.
the experience
- Holds a degree in Chemistry, Science, Biotechnology, Biochemistry, or a related field; experience in the pharmaceutical industry is an added advantage.
- Skilled in performing chemical analyses and troubleshooting laboratory equipment, with hands-on experience using instruments (e.g. analytical balances, pH meters, Karl Fischer titrators, TOC analyzers, FT-IR spectrophotometers, HPLC/UPLC systems, and gas chromatographs).
- Possesses advanced knowledge of USP/NF standards relevant to solid dosage pharmaceutical manufacturing.
- Proficient in Microsoft Office (Word, Excel, PowerPoint), Outlook, and Oracle systems, with strong English reading and writing abilities.
- Demonstrates a solid understanding of analytical and pharmaceutical sciences, including pharmacopeial standards, chemical stoichiometry, and diverse analytical methodologies.
