Analytical Quality Assurance (AQA)
Designation: Executive / Sr.Executive
* Qualification: M.Sc / B.Pharm / M.Pharm
- Years of Experience : 3 - 7 Years with relevant experience.
- Job Role : Review of Specification, STP and Raw data sheet.
- Review of AMD, AMV, AMT & PDR Documents.
- Review of calibration/preventive maintenance records of instruments and equipment.
- Review and approve the working standard qualification records.
- Review of analyst Qualification Reports.
- Review of QC, AD and Microbiology reports.
- Ensure Laboratory and documentation are up-to-date and ready to face audits any time.
- Review of chromatographic and standalone system suitability review sheet and approval of invalidated data.
- Review of Stability protocols and Analytical Data Perform the verification of audit trails in Chromeleon (HPLC, GC instruments) and Standalone instruments in Analytical Laboratory.
- Ensure all instruments/equipment’s and associated software meets the 21 CFRPart11 compliance Perform GLP checks in the Laboratory to provide input for improvements.
- Ensure Quality Control laboratory is in compliance with current industrial practices and constantly meets the regulatory requirement with zero integrity issues.
- Support the Quality Control for upkeeping of facility/systems/procedures/documentation etc.
- Handling of internal audits and Vendor audits.
- Management of Reserve samples and Stability Chambers.
- Candidate should have knowledge on major analytical software like Chromeleon/ Empower and other standalone instruments software.
- Candidate should have knowledge on investigations Candidate should have knowledge on GDP & GLP.
Interested candidates are requested to forward your updated resumes to email id: [email protected]
Job Types: Full-time, Permanent
Pay: ₹40,000.00 - ₹60,000.00 per month
Benefits:
- Commuter assistance
- Food provided
- Health insurance
- Leave encashment
- Paid sick time
- Provident Fund
Work Location: In person
