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.
Job Types: Full time, Permanent
Pay: ₹40,000.00 - ₹60,000.00 per month
Advantages:
Commuter assistance
Food provided
Health insurance
Leave encashment
Paid sick time
Provident Fund