Senior Specialist, Qc Physicochemical

Trzdev36

**
Gmp-compliant laboratory management
Drafting quality standards and sops
Analytical method validation
** Trzdev36 is seeking a Senior Specialist in Physicochemical Quality Control to manage laboratory procedures, ensure compliance with GMP regulations, and contribute to the drafting of quality standards and SOPs. The ideal candidate should have a background in chemistry or related fields, with at least three years of experience in pharmaceutical testing. **

Job Summary

  • Receive regular GMP training, regulatory training, and company role training/assessments; attend data reliability training on schedule to strengthen awareness of data reliability.
  • Be responsible for physicochemical testing related to plasmids, lentiviral vectors, and CAR‑T; maintain and update relevant SOPs and records.
  • Comply with GMP (2010 Edition), “Drug Records and Data Management Requirements (Trial),” and company data integrity policies to ensure data integrity.

Matching Summary

Match Score: 75

** Trzdev36 is seeking a Senior Specialist in Physicochemical Quality Control to manage laboratory procedures, ensure compliance with GMP regulations, and contribute to the drafting of quality standards and SOPs. The ideal candidate should have a background in chemistry or related fields, with at least three years of experience in pharmaceutical testing. **

Skills & Requirements

Must-have

  • GMP-compliant laboratory management
  • drafting quality standards and SOPs
  • analytical method validation
  • process water monitoring
  • material sampling and testing
  • quality event investigation and rectification
  • data integrity compliance (ALCOA+CCEA)

Nice-to-have

  • embraces diversity and equality
  • inclusive and diverse team
  • harnessing industry-leading skills
  • cooperate with audits

Key Requirements

  • Associate degree or above
  • Three or more years of experience
  • Familiar with GMP regulations and guidelines
  • Familiar with national pharmacopoeias
  • Familiar with quality management systems
  • Proficient in computer use

Work Rights

Not specified

Tailored Resume

Cover Letter