Executive
Executive
Posted on :
25-04-2025
Employer Active
1 Vacancy
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Job Description
Masters (Pharmaceutical Chemistry / Organic Chemistry/ Chemistry/Quality Assurance) with 47 years experience in AnalyticalQA.
Roles and responsibilities
- Analytical quality assurance support from earlystage 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 preformulation studies and scaleup 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.
Employment Type
Full-Time
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