Title:  Manager-QA of QC

Job Role : Manager QA of QC

Job Location : Mohali

Experience : 12 to 15 Years

Educational Qualification : B.Pharm / M.Pharm

Job Responsibility: 

• Review of Raw Material/Packaging Material /Stability/ Microbiology/Cleaning Method Validation/ Validation/ Finished Product Analytical data, Certificate of Analysis & related documents.
• Review and approval of Exhibit Stability Protocols.
• Preparation and review of validation /pre-validation /commercial/annual addition batch/thermal excursion/additional study stability protocol.
• Approval of additional testing requests (if required).
• Review and approval of ln-Vitro/CU and dissolution sheets.
• Review and approval of Analytical Method Transfer documents.
• Participation in handling OOS, OOT, Investigation and deviations related to
• Quality Control.
• Review and approval of weekly  and  monthly  software  verification  reports  of
• Empower.
• Periodic verification of application software on computer systems, associated with laboratory instruments with system administrator.
• Review of lab instruments calibration/preventive maintenance data.
• Review of Stability test results in NOVATEK software.
• Approval of Certificate of Analysis.
• Review and submission of analytical data to site regulatory affairs.
• To  provide  the  response  of  regulatory  affairs  and  Office  of  data  reliability queries.
• Review and approval of change control request, specification, standard test procedure and SOP in Documentum Compliance Manager System.