Senior Specialist, QC Physicochemical
On-site · Suzhou, Jiangsu, China
Job Summary
Senior Specialist in QC Physicochemical responsible for GMP-compliant laboratory area management, drafting quality standards and SOPs for analytical methods in physicochemical testing, and ensuring data integrity. Activities include drafting validation and stability protocols, managing process water/steam monitoring and sampling, conducting physicochemical tests (e.g., TOC, conductivity, pH, osmolality), entrust testing of raw materials, excipients, packaging and consumables, CoA review, and supporting assessments/changes for new materials and added tests. Will initiate investigations into quality events (deviations, OOS, data anomalies), maintain equipment and inventory for the Physicochemical Group, perform analytical method transfers/validations, support audits and regulatory submissions, and collaborate with other departments to meet GMP requirements. Must ensure data authenticity and accuracy per ALCOA+CCEA, comply with Drug Records and Data Management requirements, and support company clinical research and regulatory activities. This role is located in Suzhou Biopharmaceutical Industrial Park, Suzhou, China, and requires strong English communication and oversight of laboratory operations and documentation.
Required Qualifications
- Associate degree or above in Inorganic Chemistry, Organic Chemistry, Pharmaceutical Analysis, Biology, or a related discipline
- Three or more years of experience in pharmaceutical testing or pharmaceutical quality-related work
- Familiar with GMP regulations and guidelines, as well as national pharmacopoeias
- Familiar with pharmaceutical physicochemical laboratory practices and techniques, including testing of raw materials and packaging materials, testing of intermediates and finished products, and process water analyses
- Proficient in computer use, including Microsoft software
- Strong verbal and written communication, organization, and coordination skills, with good English listening, speaking, reading, and writing ability
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