Jobresponsibilities:
- Review the analytical reports/Calibration records in quality control (RM/PM/SFG/FG/Stability/ AMV/AMT/Microbiology)
- Review the laboratory and manufacturing investigation pertaining to incidentOOS & OOT.
- Review the investigation related to microbiological out of specification results.
- Review the Standard Analytical Procedures (SAP) and ensure the implementation of SAPs.
- Review & monitor the protocols and reports related to qualification of instrument andequipment in the quality control laboratory.
- Review the audit trail and supportive documents for investigations.
- Review analytical method validation and Pharmacopeial Verification and analytical technology transfer.
- Review the various work-flow in Labware LIMS as per respective SOPs and ensure the online completion of activities.
- Review the process validation and cleaning validation reports w.r.t. QualityControl department.
- Review the stability protocol andsummarysheets for stability evaluation
- Ensure the compliance of Data Integrity Governance and maintain Quality Culture.
- Review the analytical reports/Calibration records in quality control (RM/PM/SFG/FG/Stability/ AMV/AMT/Microbiology)
- Review the laboratory and manufacturing investigation pertaining to incidentOOS & OOT.
- Review the investigation related to microbiological out of specification results.
- Review the Standard Analytical Procedures (SAP) and ensure the implementation of SAPs.
- Review & monitor the protocols and reports related to qualification of instrument andequipment in the quality control laboratory.
- Review the audit trail and supportive documents for investigations.
- Review analytical method validation and Pharmacopeial Verification and analytical technology transfer.
- Review the various work-flow in Labware LIMS as per respective SOPs and ensure the online completion of activities.
- Review the process validation and cleaning validation reports w.r.t. QualityControl department.
- Review the stability protocol andsummarysheets for stability evaluation
- Ensure the compliance of Data Integrity Governance and maintain Quality Culture.
Jobresponsibilities:Review the analytical reports/Calibration records in quality control (RM/PM/SFG/FG/Stability/ AMV/AMT/Microbiology)Review the laboratory and manufacturing investigation pertaining to incidentOOS & OOT.Review the investigation related to microbiological out of specification result...
Jobresponsibilities:
- Review the analytical reports/Calibration records in quality control (RM/PM/SFG/FG/Stability/ AMV/AMT/Microbiology)
- Review the laboratory and manufacturing investigation pertaining to incidentOOS & OOT.
- Review the investigation related to microbiological out of specification results.
- Review the Standard Analytical Procedures (SAP) and ensure the implementation of SAPs.
- Review & monitor the protocols and reports related to qualification of instrument andequipment in the quality control laboratory.
- Review the audit trail and supportive documents for investigations.
- Review analytical method validation and Pharmacopeial Verification and analytical technology transfer.
- Review the various work-flow in Labware LIMS as per respective SOPs and ensure the online completion of activities.
- Review the process validation and cleaning validation reports w.r.t. QualityControl department.
- Review the stability protocol andsummarysheets for stability evaluation
- Ensure the compliance of Data Integrity Governance and maintain Quality Culture.
- Review the analytical reports/Calibration records in quality control (RM/PM/SFG/FG/Stability/ AMV/AMT/Microbiology)
- Review the laboratory and manufacturing investigation pertaining to incidentOOS & OOT.
- Review the investigation related to microbiological out of specification results.
- Review the Standard Analytical Procedures (SAP) and ensure the implementation of SAPs.
- Review & monitor the protocols and reports related to qualification of instrument andequipment in the quality control laboratory.
- Review the audit trail and supportive documents for investigations.
- Review analytical method validation and Pharmacopeial Verification and analytical technology transfer.
- Review the various work-flow in Labware LIMS as per respective SOPs and ensure the online completion of activities.
- Review the process validation and cleaning validation reports w.r.t. QualityControl department.
- Review the stability protocol andsummarysheets for stability evaluation
- Ensure the compliance of Data Integrity Governance and maintain Quality Culture.
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