Website Aurigene Oncology Ltd
Post Name: Executive
Skill: Development Quality Assurance
Minimum Qualification: M.Sc
Highest Qualification (Discipline): General Chemistry Pharmaceutical Chemistry
Working Language: English
Job Description:
-Masters (Pharmaceutical Chemistry / Organic Chemistry/ Chemistry/Quality Assurance) with 4-7 years’ experience in Analytical-QA.
Roles and responsibilities:
Analytical quality assurance support from early-stage development to production.
Review of analytical method development, validation protocols and reports studies of API and formulations.
Review formulation development reports and Master formula records.
Review stability protocols and reports for pre-formulation studies and scale-up studies.
Analytical method transfers across CMOs for APIs and Drug products manufacturing.
Conduct investigation against OOS encountered, with aim of root cause identification through utilization of specific QRM tools.
Review of master and executed BMRs, BPRs, cleaning records, ROAs and COAs.
Review of calibration reports of equipment calibration, external calibration.
Review incidents, investigation and CAPA reports.
Develop and review of SOPs, specifications & STP, guidelines as per regulatory requirements.
Control, distribution and issuance of SOPs, Format (s), Annexure (s) and Logbooks. Maintain and update master list of SOPs and format/s.
End Date: 08 May 2025
