Bachelor of Pharmacy professional with deep expertise in Quality Management Systems, Audit Compliance, and Validation in the Pharma Industry. Oversee site-level internal audits and ensure regulatory readiness through effective risk assessment and compliance tracking. Drive operational improvements and enhance QA processes, fostering a culture of continuous improvement and adherence to cGMP standards.
Overview
18
18
years of professional experience
Work History
Sr.Manager Internal Audit And Compliance
Eugia Pharma specialities Limited
Hyderabad, India
12.2025 - Current
Plan and execute site-level internal audits across manufacturing Five sites On quarterly basis.
Identify gaps in processes and recommend corrective/preventive actions (CAPA).
Ensure readiness for regulatory inspections.
Perform the Sterility Assurance audit across the five sites at tri monthly frequency.
Perform the Data Integrity Audit across the five sites at tri monthly frequency.
Track and report compliance metrics to senior leadership.
Responsible 483 learning implementation across the Eguia site.
Responsible for review of smoke studies across the Sites.
Assist the Sites for internal improvement and capability building of SME(s)
QA Manager
Zydus life sciences (Alidac, SEZ)
Ahemedabad, Gujrat
03.2023 - 11.2025
To monitor the Daily IPQA activities at shop floor.
Supervising process simulation media fill as subject matter expert (ensuring implementation of SOP and Protocol, compilation of batch records, Report, and subsequent review).
To ensure Aseptic process activity compliance with respect to System and Regulatory Guidelines.
Responsible to ensuring compliance during execution of process simulation studies, exhibit batches and process validation batches.
Responsible to review and approval of alarm reports, CPP, CQA, Visual inspection report and audit trial reports.
Accountable for the reserve sample maintenance, inspection and destruction of expired samples.
Responsible for review and approval of the break down issues.
Responsible for the calibration and Preventive maintenance compliance.
Responsible for review and approval of Change Control, Deviation, and CAPA Documentation.
Review and approval of Process Validation Protocols and Reports.
Review and approval of Cleaning Validation Protocols and Reports.
Review and approval of SOPs.
Member of the internal audit team (self inspection).
Responsible for batch release in Market.
Responsible for approval of trends related to utilities and environment.
Assumed responsibilities of QA Head in their absence, ensuring seamless quality assurance operations.
IPQA In-charge
Dr. Reddys Labs
Vizag, Andhra Pradesh
10.2022 - 03.2023
To monitor the Daily IPQA activities related to Vial, Cartidge and PFS Line.
Supervising process simulation media fill as subject matter expert (ensuring implementation of SOP and Protocol, compilation of batch records, Report, and subsequent review).
Approval of master BMR and BPR and review of executed BMR and BPR with associated records.
To ensure Aseptic process activity compliance with respect to System and Regulatory Guidelines.
Responsible to ensuring compliance during execution of process simulation studies, exhibit batches and process validation batches.
Responsible for the shop floor compliance and monitoring through oversight observation.
Responsible to review and approval of alarm reports, audit trial reports.
Responsible for reserve sample collection, maintenance, inspection and destruction of expired samples.
Approval of Process Validation Protocols and Reports.
Approval of Cleaning Validation Protocols and Reports.
Lead Auditor of the internal audit team (self inspection).
Responsible for batch release in Market.
Responsible for GEMBA walk in aseptic area weekly.
Responsible for review and approval of the break down issues.
Responsible for the calibration and Preventive maintenance compliance.
Responsible for approval of Change Control, Deviation, and CAPA Documentation.
QMS Incharge
Dr. Reddys Labs
Vizag, Andhra Pradesh
01.2020 - 09.2022
Work exposure as QMS in Sterile formulation.
Site work stream owner for investigation (Perimeter: Incident, OOS/OOT second phase and Market complaints).
Benchmarking the investigation report and Implementation of outcomes.
Responsible for Management of Capability building context to Investigation Tracking audit & inspection commitments and Tracking Audit readiness To carried out GAP assessment based on the regulatory guidance.
To carried out categorisation of incidents on the basis of risk assessment, Closure of incident in SAP.
To carried out verification of implementation and closure of Change control through SAP FIORI.
To assign, verification of implementation and effectiveness of CAPA and closure of CAPA through SAP.
To carried out investigation in case of Incident, OOS, OOT, Process improvement.
To Monitor the QMS tools through relevant Quality index.
To prepare the Presentation for Quality review meeting at frequencies of weekly, monthly and Tri-monthly.
To prepare self inspection schedule and monitoring of relevant action tasks.
Responsible for handling of WAR room during Audit.
Asst.Manager
Alembic pharmaceuticals Ltd.
Vadodara, India
03.2018 - 01.2020
To monitor the activity related to validation of equipments related to PFS line.
To review the documents like URS, FDS, HDS, FAT, SAT, IQ, OQ for Pre-approval and post approval.
Criticality assessment of equipments and instruments.
Supervising process simulation media fill as subject matter expert (ensuring implementation of SOP and Protocol, compilation of batch records, Report, and subsequent review).
Review of master BMR and BPR and review of executed BMR and BPR with associated records.
To ensure Aseptic process activity compliance with respect to System and Regulatory Guidelines.
Responsible to participate and ensuring compliance during execution of process simulation studies, exhibit batches and process validation batches.
Responsible for the shop floor compliance.
Responsible to review and approval of alarm reports, audit trial reports.
Responsible for the reserve sample collection, maintenance, inspection and destruction of expired samples.
Responsible for review and approval of the break down issues.
Responsible for the calibration and Preventive maintenance compliance.
Responsible for review of Change Control, Deviation, and CAPA Documentation.
Review of Process Validation Protocols and Reports.
Review of Cleaning Validation Protocols and Reports.
Preparation of training modules for new joiners in department.
Review of SOPs.
Member of the internal audit team (self inspection).
Asst.Manager
Cadila pharmaceuticals Ltd.
Ahmedabad, India
01.2012 - 03.2018
In process Quality Assurance(Manufacturing and Packing):
To ensure smooth working of IPQA activities like Line clearance, in-process checks, sampling etc at manufacturing and packing sections by guiding, monitoring shift schedule and manpower allocation.
To assist in conducting detailed investigations for non-conformances at various stages of manufacturing & packing.
To ensure c GMP compliance at shop floor.
Review of executed BMR for release to next stage.
Response to queries related batch records asked from third parties (contract giver).
Review of Master copy of Batch manufacturing record and Batch packing record.
Responsible for batch release at various manufacturing stages and packing.
Process and packing Validation.
Review of Process and packing Validation Protocol.
Coordinating in execution of validation activities at shop floor along with validation team members.
Compilation and review of In process and analytical data.
Review of Process validation summary report.
Review of protocol and report of Hold time batches.
Audit & Compliance:
Involved in different regulatory and customer audits as Subject Matter Expert.
Involved in preparation of Audit Compliance Report for different regulatory and customer audits.
Cross functional works:
Training to undersigned & Cross functional departments on Quality Management System, validation protocol, start up of critical utilizes and on many more new upcoming requirements & system as per cGMP Requirement.
Responsible to review deviation and change control forms related to shop floor.
To perform self inspection at various department monthly.
Identify the gaps in the current practices with respect to CGMP requirements and escalate to cross functional departments head for its compliance as per the regulatory norms.
Perform Risk Assessment of the process.
Perform Primary Investigation of Product failure & Market complaints.
Sr.officer
Alkem labs. Ltd.
Daman, India
03.2008 - 01.2012
Work exposure in Sterile (Vial) and solid oral dosage.
Verification of weighment sheet for the correctness of the details.
Draft batch manufacturing record reviewing.
Filled batch manufacturing record and batch packing record reviewing.
Perform all the IPQA related work in (Injectable and solid oral) formulation.
Co-ordination in process validation and cleaning validation.
Co-ordination in media fill study in Injectable.
Education
B.Pharma -
RGHUS University
Bangalore, Karnataka
2007
Skills
Aseptic process management
Aseptic technique review
Validation and simulation of processes
Airflow analysis
Data integrity compliance
Risk evaluation
Root cause investigation
Contamination control measures
Internal audits
Inspection readiness for regulations
SOP adherence assessment
Compliance monitoring
Training development
Process improvement knowledge
Languages
English
Hindi
Projects
One month Industrial training Alkem Labs Ltd. Daman in the field of Quality Assurance.
Custom Section
CGMP, Process validation training, Mr. Atul Shirgaokar
<ul><li>Company Overview: Group Company of PUIG, Spain</li><li>Team Leadership & Process Excellence: Organised the transformation of the Finance & Accounts function, establishing performance-driven goals, and embedding a culture of accountability and continuous improvement. Drove operational efficiency through process redesigns, SOP implementation and optimal resource deployment, leading to measurable improvements in turnaround time and accuracy.</li><li>Strategic Partnering with CXOs: Acted as a key advisor to the CEO, CFO, and other CXOs on business planning, pricing strategies, and business model pivots to support scale-up and profitability. Contributed to investor communications with data-backed insights to enhance stakeholder confidence and secure strategic funding.</li><li>Cross-Functional & Global Stakeholder Management: Functioned as the strategic finance business partner to cross-functional heads and the PUIG global finance team, aligning local execution with global financial strategies and compliance requirements.</li><li>ERP Transformation & System Automation: Led end-to-end ERP reimplementation to address system gaps, enforce role-based controls, and automate core finance processes—resulting in enhanced data accuracy, faster reporting and improved internal controls.</li><li>Costing, Inventory & Profitability Optimization: Designed and implemented plant-level costing models to ensure accurate COGS determination. Improved inventory management across pricing, consumption tracking, and aging analysis—enabling better working capital control and cost efficiency.</li><li>Manufacturing Finance & Statutory Compliance: Supervised end-to-end accounting for manufacturing operations and ensured full statutory compliance.</li><li>Financial Reporting, MIS & Profitability Analytics: Delivered accurate and timely monthly MIS reports, including P&L, Balance Sheet and KPI dashboards with deep-dive variance analysis across stores, business verticals, and geographies. Supported board-level decision-making through insightful presentations on financial health and business performance.</li><li>Budgeting, Forecasting & Business Planning: Led the Annual Operating Plan (AOP) and rolling forecasts, ensuring alignment with strategic objectives and market dynamics. Monitored key financial metrics to enable business decisions and proactive cost management.</li><li>Statutory, Internal & Tax Audit Management: Finalized standalone and consolidated financials under Ind AS and IFRS, ensured timely group reporting and compliance with international standards. Delivered clean and timely closures of statutory, tax, and internal audits in coordination with Big 4 auditors. Strengthened audit readiness through pre-audit diagnostics and rectification of recurring control gaps.</li><li>Regulatory Compliance & Risk Management: Ensured end-to-end compliance which includes ROC, RBI, FEMA, Income Tax, GST, Transfer Pricing, DTAA, and Customs. Reviewed cross-border contracts and transactions to ensure arm’s length pricing, accurate TDS application, and proper documentation under Transfer Pricing regulations.</li><li>Commercial Negotiation & Contract Governance: Led commercial negotiations and structured deals with vendors and franchisees. Reviewed key business contracts to ensure financial viability, risk protection, and compliance with regulatory standards.</li><li>Treasury & External Commercial Borrowing (ECB): Managed fund planning and liquidity management including ECB drawdowns, bank negotiations, and interest optimization. Improved working capital cycles through proactive cash flow forecasting and receivables control.</li><li>Internal Controls & Governance Framework: Led organization-wide reviews of internal control systems, identified process gaps, and redesigned or implemented over 40 SOPs and IFCs. Established a governance structure for financial discipline, risk mitigation, and policy compliance across departments.</li></ul> at Kama Ayurveda Pvt. Ltd. & PUIG India Pvt. Ltd.<ul><li>Company Overview: Group Company of PUIG, Spain</li><li>Team Leadership & Process Excellence: Organised the transformation of the Finance & Accounts function, establishing performance-driven goals, and embedding a culture of accountability and continuous improvement. Drove operational efficiency through process redesigns, SOP implementation and optimal resource deployment, leading to measurable improvements in turnaround time and accuracy.</li><li>Strategic Partnering with CXOs: Acted as a key advisor to the CEO, CFO, and other CXOs on business planning, pricing strategies, and business model pivots to support scale-up and profitability. Contributed to investor communications with data-backed insights to enhance stakeholder confidence and secure strategic funding.</li><li>Cross-Functional & Global Stakeholder Management: Functioned as the strategic finance business partner to cross-functional heads and the PUIG global finance team, aligning local execution with global financial strategies and compliance requirements.</li><li>ERP Transformation & System Automation: Led end-to-end ERP reimplementation to address system gaps, enforce role-based controls, and automate core finance processes—resulting in enhanced data accuracy, faster reporting and improved internal controls.</li><li>Costing, Inventory & Profitability Optimization: Designed and implemented plant-level costing models to ensure accurate COGS determination. Improved inventory management across pricing, consumption tracking, and aging analysis—enabling better working capital control and cost efficiency.</li><li>Manufacturing Finance & Statutory Compliance: Supervised end-to-end accounting for manufacturing operations and ensured full statutory compliance.</li><li>Financial Reporting, MIS & Profitability Analytics: Delivered accurate and timely monthly MIS reports, including P&L, Balance Sheet and KPI dashboards with deep-dive variance analysis across stores, business verticals, and geographies. Supported board-level decision-making through insightful presentations on financial health and business performance.</li><li>Budgeting, Forecasting & Business Planning: Led the Annual Operating Plan (AOP) and rolling forecasts, ensuring alignment with strategic objectives and market dynamics. Monitored key financial metrics to enable business decisions and proactive cost management.</li><li>Statutory, Internal & Tax Audit Management: Finalized standalone and consolidated financials under Ind AS and IFRS, ensured timely group reporting and compliance with international standards. Delivered clean and timely closures of statutory, tax, and internal audits in coordination with Big 4 auditors. Strengthened audit readiness through pre-audit diagnostics and rectification of recurring control gaps.</li><li>Regulatory Compliance & Risk Management: Ensured end-to-end compliance which includes ROC, RBI, FEMA, Income Tax, GST, Transfer Pricing, DTAA, and Customs. Reviewed cross-border contracts and transactions to ensure arm’s length pricing, accurate TDS application, and proper documentation under Transfer Pricing regulations.</li><li>Commercial Negotiation & Contract Governance: Led commercial negotiations and structured deals with vendors and franchisees. Reviewed key business contracts to ensure financial viability, risk protection, and compliance with regulatory standards.</li><li>Treasury & External Commercial Borrowing (ECB): Managed fund planning and liquidity management including ECB drawdowns, bank negotiations, and interest optimization. Improved working capital cycles through proactive cash flow forecasting and receivables control.</li><li>Internal Controls & Governance Framework: Led organization-wide reviews of internal control systems, identified process gaps, and redesigned or implemented over 40 SOPs and IFCs. Established a governance structure for financial discipline, risk mitigation, and policy compliance across departments.</li></ul> at Kama Ayurveda Pvt. Ltd. & PUIG India Pvt. Ltd.
<ul>
<li>- Leading internal audit, process audit, and FSSAI compliance audit for Dmart Ready’s operations.</li>
<li>- Responsible for SOP review and implementation across key warehouse and distribution locations.</li>
<li>- Collaborating with operations and compliance teams to ensure regulatory adherence, and operational efficiency.</li>
<li>- Identifying control gaps and suggesting corrective actions through comprehensive audit reports.</li>
</ul> at Avenue E-Commerce Ltd. (Dmart Ready)<ul>
<li>- Leading internal audit, process audit, and FSSAI compliance audit for Dmart Ready’s operations.</li>
<li>- Responsible for SOP review and implementation across key warehouse and distribution locations.</li>
<li>- Collaborating with operations and compliance teams to ensure regulatory adherence, and operational efficiency.</li>
<li>- Identifying control gaps and suggesting corrective actions through comprehensive audit reports.</li>
</ul> at Avenue E-Commerce Ltd. (Dmart Ready)