Kumar Pardeep Email & Phone Number

India

Handling of Audit and ensure the Compliance at site-To perform the internal Audits and Gemba walk at site.Ensure the compliance at site and implement the Global CAPA.Handle the external Auditors and ensure the timely submission of audit response.Handling of Qualification/Validation activity at site-Review of Validation Master Plan and Site Master File with regards to facility, equipment, process, cleaning and utility.Review of Qualification documents of computerized system validation, (URS, HLRA, Vendor Assessment, FRS, CS, IQ, OQ, PQ, TM and validation plan).Review of Qualification activities of the new equipment’s, facility and HVAC, Compressed air system etc.Review of Re-qualification activities of the equipment’s, HVAC, Compressed air system etc.Review of Cleaning Validation Master Plan, New product assessment for worst case, MACO calculation and cleaning validation of drug product.Review of Process Validation Protocol and reports.Handling of QA Documentation-Monitoring of document issuance and retrieval and document storage.Review of master BMR/BPRs of drug product.Review of Process Validation Protocol and report.Monitoring of document issuance and retrieval and document storage.Review of master BMR/BPRs of drug product.Review of Process Validation Protocol and report.Monitoring of document issuance and retrieval and document storage.Review of master BMR/BPRs of drug product.Review of QA and site SOPs. as per cGMP and regulatory requirements.Co-ordinate for the Compliance Audit/ Self Inspection in the facility.Handling of QMS Activities-Review of investigation for Deviation, Market complaint and Hub complaints.Review of change controls related to facility, equipment and process.Review of deviations & investigation reports and CAPA activities (implementation, review, effectiveness check & their closure).Review of product APQR and recommendations.Responsible for batch release at site.

Review of Validation Master Plan and Site Master File with regards to facility, equipment, process, cleaning and utility.Review of Qualification documents of computerized system validation, (URS, HLRA, Vendor Assessment and validation plan).Review of Qualification activities of the new equipment’s, facility and HVAC, Compressed air system etc.Review of Cleaning Validation Master Plan, Cleaning Validation protocol and report.Review of Process Validation Protocol and report.Monitoring of document issuance and retrieval and document storage.Review of master BMR/BPRs of drug product.Review of QA and site SOPs. as per cGMP and regulatory requirements.Co-ordinate for the Compliance Audit/ Self Inspection in the facility.Review of investigation for Deviation, Market complaint and Hub complaints.Review of change controls related to facility, equipment and process.Review of deviations & investigation reports and CAPA activities (implementation, review, effectiveness check & their closure).Review of product APQR and recommendations.Responsible for batch release at site.

To review the Master Batch Production Record (Manufacturing Part & Packing Part) for all Domestic and Export market.Handling of Master Formula Card (MFC) – Receiving, distribution, keeping and control of MFC and coordination with R&D and RA for master documents.Responsible for preparation and review of QA SOPs. as per cGMP.To co-ordinate for the Compliance Audit/ Self Inspection in the facility.

To review the Master Batch Production Record (Manufacturing Part & Packing Part) for all Domestic and Export market.Handling of Master Formula Card (MFC) – Receiving, distribution, keeping and control of MFC and coordination with R&D and RA for master documents.To verify and approve the request for SFG code creation / extension. FG code creation / extension.To verify and approve the request for SFG BOM creation, FG BOM creation, and SFG & FG BOM changes.To ensure the correct doc. (batch production record) is uploaded in SAP and same is attached to PRT in master recipe.Preparation and Review of QA SOPs. as per CGMP.To review the Executed Batch Documents before submission to Regulatory Affairs Department.

Responsible for the monitoring of raw material/packing material dispensing.Responsible for the monitoring of manufacturing and packing activity as per the batch record.To give line clearance in the manufacturing and packaging areas.To ensure compliance with existing SOPs.Responsible to perform in-process checks in the manufacturing and packing areaResponsible to fill online the BMR/BPR as per the process.

Bachelor, Chemistry, First

Master, Chemistry, First

High School, Science