SAP ERP system
Sachinkumar Herwade
Manager Quality Control
Thane
Summary
A established pharmaceutical quality professional with 25+ years of strong experience in Quality Control, Quality Assurance across reputed global organizations including Sandoz, Alembic, Dr. Reddy’s Labs and Okasa Pharma (Cipla sister concern) with Core competencies in the areas, QC operations, Investigations, Data Integrity, Batch Release and Compliance. Passionate about elevating quality culture through training, continuous improvement, and robust governance. Committed to building strong, compliant, future-ready quality control systems with a focus on operational excellence, risk mitigation, regulatory compliance alignment and continuous improvement.
Overview
26
26
years of professional experience
3
3
Languages
Work History
Manager Quality Control
SANDOZ PVT.LTD.
Navi Mumbai
02.2008 - Current
- Ø Leading a team of 18 quality control laboratory experts to ensure and sustain compliance in laboratory and quality systems.
- Ø Responsible for planning, review and release testing of finished product, stability and RM/PM for commercial and registration projects.
- Ø Review/approve the documentation for computer system validation deliverables as and when required.
- Ø Ensure CSV and Compliance w.r.t 21 CFR Part 11, EU Annex 11 and Good Automated Manufacturing Practices. Support during internal or external inspections.
- Ø Ensure ERES compliance assessment, Gap Remediation, Effectiveness check for remediation.
- Ø Efficient management of department for resource optimisation and expertise utilisation to achieve productivity and compliance.
- Ø Accountable for implementation of Site and Global SOP’s applicable to Quality control and ensure effectiveness check.
- Ø Training to QC department and Business Users on site specific and Global SOP’s for QC associates as required.
- Ø Predictive compliance activities like review of regulatory guidance’s, regulatory observations etc.
- Ø Performing assessment/approvals etc. in available QMS tools for CCR, CAPA and deviation.
- Ø Guidance for adequate investigation, documentation and timely closure of incidents/deviations observed during QC testing.
- Ø Participate & presentation in Management Review Meetings.
- Ø Governing and monitoring Cost reduction and resource optimization processes.
- Ø Subject Matter Expert for overall laboratory compliance against regulatory requirements.
- Ø Preparation, review and execution of Internal and external audit response reports against observations. Response writing for regulatory observations and ensure responses are complete and properly closed.
- Ø Impact assessment and control implementations based on regulatory observations
- Ø Global CAPA and effectiveness check at the sites.
- Ø 21 CFR Part 11/Annex 11 compliance assessment and Gap remediation.
- Ø Assess product, compliance or operational risk and develop risk management strategies like FMEA.
- Ø Conduct QC associate training on compliance related topics, new implementations, policies and procedures.
- Ø Assessment of potential impact on organisation about emerging regulatory guidance’s, industry changes etc
- Ø Ensure inspection readiness with respect to laboratory and support during Regulatory inspection like USFDA, EAEU, TGA, PMDA etc.
- Ø QMS monitoring for change control, deviation, CAPA management etc.
Sr. Executive, QC Section Head
Alembic Ltd.
Vadodara
09.2005 - 02.2008
- ØLed US FDA auditor interactions on laboratory system controls and electronic data review.
- Ø Responsible for planning, review and release testing of finished product, stability and RM/PM.
- Ø Ensuring System and procedural controls in laboratory systems.
- Ø Handling of incident, deviation and change management activities for documents, system & instruments.
- Ø Accountable for Method Validation, Method transfer, Method Verification & Cleaning validation protocols.
- Ø Comparative studies using HPLC, GC, UV, dissolution etc.
- Ø Testing and release of different formulations like tablets, capsules, Pellets etc.
- Ø Implementation of CAPAs based upon identified root cause during OOS, OOT, OOE investigations.
- Ø Preparation, updation and execution of Calibration and validation activities.
- Ø Review/Approval of Analytical reports/Calibration records & other GMP documents.
- Ø Monitor the upkeep of stability chambers, stability schedule register; pull out logs, stability documents etc.
- Ø Training for new and existing staff with respect to predefined training schedule and training needs.
- Ø Self- inspection for onsite various departments as per schedule and compliance for observations.
- Ø Support to Regulatory inspection like USFDA, WHO, external customer inspection etc.
AR & D Executive
Dr. Reddy’s Laboratories
Hyderabad
12.2003 - 09.2005
- Ø Development Analysis of Formulation products like tablet, capsules etc.
- Ø Stability study testing for different types of formulation like tablet, capsule.
- Ø Calibration and maintenance of instruments & equipments like HPLC, UV, IR, Disso tester etc.
- Ø Multimedia dissolution testing of development projects.
- Ø Preparation and review of testing protocols.
- Ø Preparation and Review of standard operating procedures.
- Ø Method verification and transfer activities.
- Ø Comparative studies for dissolutions.
- Ø Report review for routine analysis.
QC/QA Chemist
Okasa Pharma
Satara
06.2000 - 12.2003
- Ø Sampling of RM, PM and various type formulations, Packline inspections, IPQA checks during production.
- Ø Testing of cleaning validation samples (rinse/Swab), OSD, syrups, injections etc.
- Ø Handling & calibration of instruments like Balance HPLC, GC, UV, KF etc.
- Ø Stability studies and Process Validation of Formulation Products (Tablets, Capsules, Dry syrups).
- Ø Preparation and maintenance of Reference/working standards.
- Ø Review/Approval of Analytical reports/Calibration records & other GMP documents.
- Ø SOP’s for newly installed instruments/equipment in the laboratory area.
- Ø Stability study protocol execution & trending of Results.
- Ø Worked for regulatory approved plants like MHRA, TGA etc.
- Ø QMS handling for change control, deviations, incidents, OOS, OOT, in QA and QC Operations.
- Ø QA documentation like BMR/BPR etc.
- Ø Document issuance, retrieval, control and records.
- Ø Batch release, dispatch, rejection documentation.
Education
Bachelor of Pharmacy -
Appasaheb Birnale College of Pharmacy
Sangli 04.2001 -
Skills
Laboratory systems, data integrity governance
Quality Investigations: OOS/OOE/OOT
Deviation and CAPA Management
Additional Information
Ø Establishing annual QC budget plans, defining resource needs, and tracking expenses against approved budgets to ensure financial discipline and alignment with organizational goals.
Ø Monitoring monthly cost performance, identifying variances, and implementing corrective measures to optimize spending while maintaining operational efficiency.
Software
QMS handling tools (GXQEM, Condor etc)
Microsoft Office
Timeline
Manager Quality Control
SANDOZ PVT.LTD.
02.2008 - Current
Sr. Executive, QC Section Head
Alembic Ltd.
09.2005 - 02.2008
AR & D Executive
Dr. Reddy’s Laboratories
12.2003 - 09.2005
Bachelor of Pharmacy -
Appasaheb Birnale College of Pharmacy
04.2001 -
QC/QA Chemist
Okasa Pharma
06.2000 - 12.2003
Team Management
Ø Creating a work environment that fosters high performance and motivates the team to consistently deliver strong results.
Ø Managing daily planning and oversight by optimizing resources and utilizing individual expertise effectively.
Ø Organizing structured training programs covering CSV, Data Integrity, GLP, cGMP, Operations, and Safety to enhance team capability.
Ø Conducting annual performance reviews and appraisals to support employee development and alignment with organizational goals.
Documentation
Ø Preparing and updating SOPs, stability study protocols, and raw data worksheets.
Ø Reviewing and approving analytical results, batch control records, and release documents.
Ø Preparation and review of risk assessment reports, reduced testing assessments etc. to improve lab efficiency.
Quality Control & Compliance
Ø Implementing the SANDOZ global procedures, including Quality Modules and SOPs, across the assigned clusters.
Ø Ensuring the laboratory follows all requirements for handling OOS, OOE, deviations, and other quality events.
Ø Maintaining Data Integrity for all GMP‑regulated documents and systems.
Ø Leading deviation handling, change control activities, and CAPA implementation within QC.
Ø Supporting market complaint investigations and ensuring they are resolved on time.
Ø Overseeing in‑process checks and preparing accurate QC reports for decision‑making.
Ø Monitoring product and process quality to ensure compliance with GMP, GLP, and all required standards.
Ø Preparing, reviewing, and updating technical quality documents and change control procedures.