Senior Executive-QA
Core
Reviewing audit trails and releasing analytical data for intermediates, finished products, and stability batches in a pharmaceutical CDMO.
Role type
Senior Quality Assurance Executive (Analytical Data Release)
Builds
Released intermediates, finished products, and stability data compliant with GMP.
Domain
Pharmaceutical manufacturing / Quality Control
Required skills
Analytical data review, Audit trail verification, SOP compliance verification, Contamination identification, Incident reporting, Batch release authorization
Preferred skills
Laboratory system compliance auditing, Logbook verification
Technologies
Chromatographic instruments, Non-chromatographic instruments, Laboratory Information Management Systems (LIMS)
Responsibilities
Review audit trails of chromatographic and non-chromatographic instruments, Release intermediates, stability batches, and finished products based on analytical data review, Verify logbooks for completeness, Identify and report potential contamination areas, Verify SOP compliance on the shop floor, Conduct audits for laboratory system compliance, Report incidents, accidents, or near misses
Seniority
Senior, hands-on IC
