Manager QA/QC - Edge Pharmaceuticals Pvt. Ltd. - Lower Parel, Mumbai
(2023-07)
Responsible for quality assurance and quality control activities across QA/QC departments.
- Responsible for review and approval of finished product COA and signing of Technical documents.
- Management of Market complaints i.e. investigation, CAPA plan, monitoring of CAPA & closing the same.
- Review the documentation of the Process and Packaging Validation, Protocol and Reports.
- Review of quality documentation for Regulatory submissions related to products manufactured at manufacturing location.
- Responsible for Vendor Audit of RM and PM.
- Reviewing of Master Formulation Record and Master Packaging Records
- To review data of APQR (Annual Product Quality Review) for all manufactured products.
- Reviewing all QA SOPs.
- Review of Various Protocols and reports. E.g. Stability Study and Hold Time Study etc.
- Conduct self-inspections at various contract manufacturing sites as per schedule.
- Internal/external contact for queries related to product compliance and quality.
- Assist for readiness for regulatory audits to sites.
- Review of shade cards of carton, foil, and leaflet as and when required.
- Routinely visit to contract manufacturing sites to monitor the quality and compliance of manufactured products.
- Technical support to the contract manufacturing activities at multiple locations.
- Support to F & D, Regulatory Affairs. Production, Quality Control for smooth documentation process.
- To review and approve of analysis report of Raw Material, Packing Material, in-process and Finished product.
- To review and approve the analytical method validation protocol and report.
Deputy Head CQA - Fredun Pharmaceuticals - Lower Parel, Mumbai
(2021-03 - 2023-07)
Responsible for corporate quality assurance activities including line clearance, document review, and compliance management.
- Line clearance activity at different level such as Dispensing, Manufacturing, Packaging and Dispatch.
- To issue Protocol, BPR and Formats as per requisition by departments.
- To review the executed BMR, BPR, ECR and Analysis Report.
- Review of production Logbook.
- Review of BMR online with respect to Reconciliation at each stage.
- Handling of change Control.
- Handling of Deviation Report.
- Handling of CAPA and Market Complaint.
- Preparation of SOP.
- Preparation of Annual product Quality review (APQR).
- Preparation of process validation protocol and report.
- Work on Foreign Audit Compliance report.
- Conduct training program.
- Internal/external contact for queries related to product compliance and quality.
- Assist for readiness for regulatory audits to sites.
- Plan to perform compliance QA rounds/ Quality audits in various departments to verify the GMP compliance.
- Routinely visit to manufacturing site to monitor the quality and compliance of manufactured products.
- Facilitate to conduct various regulatory /customer audit whenever required.
- Conduct the Vendor Audits for RM and PM as per predefined schedule and responsible for audit compliance within time period.
Assistant Manager QC - Qualigens Pharma Pvt, Ltd. - Khopoli
(2020-01 - 2021-02)
Responsible for quality control activities including analytical review, stability management, and compliance.
- To follow the relevant standard operation procedure during documents review.
- Daily coordination with production and QA for Sampling Plan and release Plan.
- To ensure that Good laboratory practices are followed in laboratory.
- Review of all routine analytical reports as per Specification and STP w.r.t GLP.
- Review of Raw Material, Inprocess, Finished Product and Stability Specification, Standard Test Procedure (STP) and Analytical Work Records.
- Review of Stability Study Reports for correctness and completeness.
- Ensure Data Integrity during review of CGMP documents.
- Day to day planning of in process, intermediate and finished product sample analysis and ensure timely release of sample results.
- Involved in Stability management activities such as preparation & review of stability protocols & reports, trending of stability data.
- Carrying out the Transport Validation activity. Planning of instrument Calibration as per Schedule and ensure all QC instrument and equipments are complies with calibration protocol.
- Supportive to internal audit as and when required.
- Solve the queries from cross-functional department for related to product compliance and quality.
Sr. Executive QA - Sandoz Pvt, Ltd (Novartis Group) - Mumbai
(2015-01 - 2019-09)
Responsible for quality assurance activities including product release, batch certification, and regulatory compliance.
- Technical release / rejection of RM, PM, SFG and FG through SAP system.
- Generation and provide COA and COC to Market Authorization.
- To comply self-inspection /audit points.
- Review of deviations, OOS / OOT / incidents, nonconforming products w.r.t. QC.
- Preparation and completion of Annual product review (APR) & Product quality review (PQR) as per SOP and schedule.
- Assist in planning, execution, and release of finished product on timely manner.
- Supportive to internal audit as and when required.
Sr. Executive QC - Sandoz Pvt, Ltd (Novartis Group) - Mumbai
(2013-04 - 2014-12)
Responsible for quality control activities including analytical protocols, method validation, and deviation handling.
- Review of Analytical Protocols, Analytical method validation protocols & reports, Analytical Method transfer protocols & reports.
- Preparation of standard operating procedure, stability protocols, stability reports.
- Handling of deviations, OOS / OOT / incidents, non-conforming products, market complaints & investigations.
Executive QC - Sandoz Pvt, Ltd (Novartis Group) - Mumbai
(2010-02 - 2013-03)
Responsible for analytical analysis and instrument calibration.
- Analysis of SFG, FG and Satibility samples.
- Calibration of HPLC, Analytical Balance, UV, PH meter and Dissolution etc.
QC Officer - Watson Pharma Ltd. - Verna, Goa
(2009-08 - 2010-02)
Responsible for analytical method validation and analysis of pharmaceutical products.
- Analytical Method Validation of API and finish products.
- Analytical method Transfer of API and finish products.
- Analysis of Finished product samples
QC Chemist - Glenmark Generics Ltd - Mapusa, Goa
(2008-07 - 2009-07)
Responsible for analytical sample analysis.
- Analysis of SFG, FG and Satibility samples.
Analytical Chemist - Sitec Labs Pvt Ltd. - Vikhroli, Mumbai
(2005-10 - 2008-07)
Responsible for analytical analysis and instrument calibration.
- Analysis of SFG, FG and Satibility samples.
- Calibration of Analytical Balance, UV, PH meter.
- Handling of Instruments UV-VIS Spectrophotometer, AAS etc.
