Sandip Garud

Manager QA/QC

Talent

MumbaiMember since September 5, 2026

Quality ControlQuality AssuranceCorporate Quality AssuranceQMSVendor Audit & QualificationInternal AuditcGMP ComplianceRegulatory Audit & ComplianceSAPERPHPLCGMPData IntegrityCAPAChange ControlBatch ReleaseAPQRStability ManagementAnalytical Method ValidationStability ProtocolsProcess ValidationInstrument CalibrationAASProblem SolvingTeam HandlingInternal audit & cGMP ComplianceBatch release through SAP and ERP systemRM/PM, Artwork code creation through ERPReview of SOPs, Artworks & Analytical DocumentsAPQR review

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Quality ControlQuality AssuranceCorporate Quality AssuranceQMSVendor Audit & Qualification

About

Total 20.0 years professional experience in Quality Control, Quality Assurance &

• Corporate Quality Assurance. Expertise in QMS, Vendor Audit &

• Qualification, Internal audit & cGMP Compliance, Regulatory Audit &

• Compliance. In addition, Batch release through SAP and ERP system along with RM/PM, Artwork code creation through ERP. Review of SOPs, Artworks &

• Analytical Documents for correctness and completeness, APQR review. Handling of QMS. Strong command on laboratory instruments such as HPLC, UV, IR and Dissolution etc. Excellent team handling skill with minimum resources. Good knowledge of GMP, expert in data integrity issue handling. Strong problem solving & trouble shooting skill.

Experience in audit preparation for WHO, MOH Kenya, NAFDAC EAEU, USFDA health authorities.

Experience

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.