Scientist, IPC Analyst
WuXi AppTec · You have
Job description
About the role
The Scientist, IPC Analyst will work in a pharmaceutical laboratory environment, performing in‑process control (IPC) tests and supporting analytical activities. The role requires strict adherence to GMP standards, accurate documentation, and collaboration with cross‑functional teams.
Key responsibilities
- Perform IPC tests according to established analytical procedures.
- Conduct laboratory tests, calculations, and review lab records.
- Document lab events, out‑of‑specifications, deviations and participate in investigations.
- Maintain and troubleshoot laboratory instruments, reporting any issues promptly.
- Update lab procedures and ensure their execution.
- Support lab management, uphold 5S, EHS, and safety standards.
- Communicate with technical operations and QC project teams to ensure smooth testing.
- Study regulatory documents (BP, USP, JP, EP) and apply them when updating internal procedures.
- Participate in customer audits and government inspections, addressing findings to maintain GMP compliance.
- Track work progress, strengthen internal and external client relationships, and handle ad‑hoc tasks as assigned.
Required profile
- Diploma or degree in Pharmacy, Chemistry, or a related field; fresh graduates are welcome.
- Understanding of pharmaceutical production, testing, quality management, and GMP regulations.
- Proficiency in English (and Chinese preferred) for communication with stakeholders.
- Familiarity with data integrity requirements for analytical software; experience in computerized systems validation is a plus.
- Strong problem‑solving, coordination, and communication skills; ability to work under pressure.
- Willingness to work shift hours and complete a minimum three‑month training period in China.
Required skills
- IPC testing and analytical procedure execution.
- Laboratory instrumentation operation and maintenance.
- Preliminary troubleshooting of lab equipment.
- GMP compliance and documentation.
- Regulatory knowledge of BP, USP, JP, and EP.
- Computerized systems validation and data integrity management.
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Published 2 days ago
Expires 1 month from now
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