We’re hiring! Anthem invites applications for Quality Assurance Auditor – GLP.
Responsibilities:
- Assure Test Facility Management, compliance to OECD Principles of GLP and terms and conditions of National GLP Compliance Monitoring Authority with respect to GLP functions.
- Conduct Study, Facility and Process Based Inspections and vendor audits.
- Prepare Standard Operating Procedure(s) to describe procedures related to Quality Assurance, Management SOPs as applicable in compliance with principles of GLP.
- Review SOPs to support applicable regulatory requirements specific to system compliance.
- Review Master Schedule for accuracy and completeness and facility general documents like IQ, OQ & PQ
- Identify critical phases of a GLP study for in-process audit with the Study Director.
- Issue QA statement to GLP study after Study Director has signed the GLP Compliance Statement
Qualification: M.Sc (Biotechnology/Microbiology/Chemistry)/ M. Pharm/ Veterinary Sciences with 2-4 years of industrial experience. The following skill set will be an added advantage:
- Preclinical Toxicology studies
- Microbiology (AMES studies)
- Physico-Chemical Studies
- Analytical/bioanalytical studies
Applicants can send their resumes to careers.qa@anthembio.com
