Preparation and Implementation of VMP (Validation Master Plan ) ,SMF(Site Master File) & QM(Quality Manual).
Preparation and implementation of SOPS, formats/logs, calibration planner & validation planner etc.
Handling of audit (Local & Regulatory).
Handling of market complaint & product recall.
Handling of NCR,Deviations,Change control & CAPA with proper justification, tracking and follow-up.
Review of Validation/Revalidation protocols & Reports.
Review of qualification / Re-qualification Protocols and Reports.
Review of deviations, change control with CAPA.
Review of calibration Reports.
Approval of filled BMR/BPR/MFR and all quality related documents.
Execution of process validation, cleaning validation, analytical method validation & hold time study.
Execution of temperature mapping of controlled area.
Execution of self inspection.
Assess batch and quality documents to release the lot.
Execution & Preparation of Validation/Revalidation protocols & Reports.
Execution & Preparation of qualification / Re-qualification Protocols and Reports.
Execution of Issuance records for BMR, BPR and relevant formats/log books.
To ensure that equipments,instruments,system and process are calibrated,validated and qualified within the defined period.
To re-enforce good documentation and cGMP during manufacturing of each stage.
To ensure that line clearance is done before start of each activity.
To ensure Environmental conditions are within the limits in respective area of the operation.
To ensure cleanliness and sanitation of manufacturing area.
Providing Training to concerned department on cGMP and other operational attributes.
Interact with IPQA/IPQC & manufacturing personnel during day-to-day operations to reinforce GMP compliance.
Responsible for overall quality assurance activity.
Review and Approval of QC/MB related documents.