Subha Prakash Tripathy
Daman
Summary
Experienced Quality Assurance professional with over 18 years in pharmaceutical manufacturing, focusing on regulatory compliance and audit management. Expertise in global regulatory inspections, including US FDA and EU GMP, alongside strong skills in Computer System Validation, Data Integrity, and CAPA management. Demonstrated ability to enhance quality systems and lead cross-functional teams to achieve compliance and audit readiness.
Overview
3
3
Languages
1
1
Certification
19
19
years of professional experience
Work History
Deputy Manager – Quality Assurance
Senador Pharmaceuticals Pvt. Ltd.
Gujarat
08.2018 - Current
- Led and supported multiple global regulatory inspections, ensuring high compliance standards and successful audit outcomes
- Managed end-to-end audit lifecycle, ensuring thorough preparation, effective compliance responses, and timely CAPA tracking and closure
- Coordinated front room and back-room audit activities as SME, ensuring inspection readiness
- Conducted vendor audits and internal audits to strengthen quality systems and regulatory compliance
- Oversaw Computer System Validation (CSV) activities, ensuring adherence to URS, validation plans, risk assessments, and compliance with 21 CFR Part 11
- Implemented data integrity controls and conducted Data Integrity Risk Assessments (DIRA) across GxP systems
- Managed TrackWise EQMS audit module including audit creation, CAPA management, and closure
- Led deviation investigations, CAPA effectiveness checks, and root cause analysis using structured methodologies
- Conducted gap assessment for updated regulatory guidance documents, formulating action plan to address identified gaps via appropriate QMS procedures
- Delivered GMP and compliance training programs across departments
Executive – Quality Assurance
Emcure Pharmaceuticals Ltd.
Pune
04.2015 - 08.2018
- Managed audit compliance activities, ensuring readiness for regulatory inspections
- Conducted internal audits and ensured closure of audit observations within due timeline
- Conducted internal audits and ensured timely closure of audit observations
- Prepared Audit Compliance response report, ensuring completeness of evidence binder
- Supported QMS activities including change control, documentation, and risk management
- Conducted GMP training sessions for employees to enhance compliance knowledge. to various levels of employees ensuring high compliance standards
Sr. Executive – Training & Development
Wockhardt Limited
Aurangabad
02.2014 - 04.2015
- Evaluated training effectiveness and ensured compliance with regulatory requirements to enhance training outcomes
- Designed and implemented GMP training programmes that improved departmental adherence to regulatory standards
- Developed training modules for quality systems and regulatory guidelines to support team knowledge and compliance
- Executed training documents during audit to ensure compliance
Technical Assistant – Quality Assurance
Torrent Pharmaceuticals Ltd.
Ahmedabad
07.2012 - 01.2014
- Conducted In-Process Quality Assurance (IPQA) checks, ensuring Line Clearance, performing in-process sampling, and compiling Batch Manufacturing Records for accurate quality control
- Supported QA activities by managing documentation, conducting audits, and overseeing compliance monitoring to ensure regulatory adherence
- Investigated customer complaints, providing effective solutions and managing deviations and quality investigations to enhance customer satisfaction
QA Officer
Claris Life Sciences Ltd.
12.2011 - 07.2012
- Conducted sampling of in-process and finished products to verify adherence to quality standards.
- Conducted Line Clearance, In Process Quality Checks at various manufacturing stages including In-process sampling, AQL, online review and compilation of Batch Manufacturing Records
- Issued documents for compliance and quality control to maintain regulatory standards.
QA/QC Officer
J.B. Chemicals & Pharmaceuticals Ltd.
Daman
12.2009 - 12.2010
- Prepared and reviewed quality documents, including SMF, quality manual, master batch records, and process validation protocols and reports, ensuring regulatory compliance and accuracy
- Conducted line clearance and in-process quality checks at manufacturing stages, including in-process sampling, AQL, online review, and compilation of batch manufacturing records to ensure compliance with quality standards
- Assisted in issuing quality assurance documentation, contributing to streamlined QA processes
QA Officer
Mepro Pharmaceuticals Pvt. Ltd.
Gujarat
11.2007 - 11.2009
- Prepared and reviewed quality documents including SMF, quality manual, master batch records, and process validation protocols and reports to maintain documentation accuracy and consistency
- Issued quality assurance documents to support regulatory compliance and operational integrity
- Conducted line clearance and in-process quality checks to ensure compliance with manufacturing standards
Education
M.Pharm - Pharmaceutical Technology
Berhampur University
Berhampur, Odisha01-2010
B.Pharm -
Biju Patnaik University of Technology
Odisha01-2006
Skills
- Regulatory compliance
- Quality management
- System validation
- Data integrity
- Deviation management
- CAPA management
- Change management
- Complaint handling
- Product recall and withdrawal
- Vendor management and audits
- GMP training and development
- Process validation
- Operational excellence (6S, GEMBA, DMAIC)
- Management review meetings (MRM)
- Gap analysis on GMP guidance documents
- Microsoft Office (Word, Excel, PowerPoint)
- TrackWise
- SAP
- LIMS
Certification
- Global Quality Auditor Training
- ISPE Training – Quality Metrics & CSV
- Lachman Consultants – cGMP & Data Integrity
- ISO 14001:2015 & ISO 45001:2018 Internal Auditor
- Train the Trainer Certification
Accomplishments
- Successfully supported multiple global regulatory audits with strong compliance outcomes.
- Strengthened QMS and audit readiness processes across manufacturing sites.
- Implemented robust data integrity frameworks for GxP computerized systems.
- Improved CAPA effectiveness and reduced recurrence of deviations.
- Delivered impactful GMP training programs across cross-functional teams.
Languages
English
Hindi
Odia
Custom
This is here by informing you that the above furnished data are true to the best of my knowledge.
Timeline
Deputy Manager – Quality Assurance
Senador Pharmaceuticals Pvt. Ltd.
08.2018 - Current
Executive – Quality Assurance
Emcure Pharmaceuticals Ltd.
04.2015 - 08.2018
Sr. Executive – Training & Development
Wockhardt Limited
02.2014 - 04.2015
Technical Assistant – Quality Assurance
Torrent Pharmaceuticals Ltd.
07.2012 - 01.2014
QA Officer
Claris Life Sciences Ltd.
12.2011 - 07.2012
QA/QC Officer
J.B. Chemicals & Pharmaceuticals Ltd.
12.2009 - 12.2010
QA Officer
Mepro Pharmaceuticals Pvt. Ltd.
11.2007 - 11.2009
M.Pharm - Pharmaceutical Technology
Berhampur University
B.Pharm -
Biju Patnaik University of Technology