Akash Pandey
Senior Officer – QA (QMS & Documentation)
Prayagraj
Summary
Dynamic Quality Management professional with extensive experience at Sun Pharmaceutical Industries, excelling in CAPA management and regulatory compliance. Proven ability in leading investigations and fostering team collaboration to drive continuous improvement. Skilled in risk assessment and report writing, ensuring adherence to cGMP standards while enhancing operational efficiency.
Committed public servant displays sound judgment under pressure in life-threatening and emergency scenarios and situations. Watchful and diplomatic professional preserves public safety, fights crime and prevents loss of life. Recognized for heroic acts and police duty excellence.
Overview
7
7
years of professional experience
2
2
Languages
Work History
Senior Officer – QMS & Quality System
Sun Pharmaceutical Industries
03.2025 - Current
- Handling end-to-end Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements (USFDA, MHRA, WHO-GMP).
- Managing deviation lifecycle , including investigation, root cause analysis (RCA), impact assessment, and timely closure.
- Leading CAPA management , including initiation, tracking, effectiveness checks, and closure.
- Handling change control system , including risk assessment (QRM), impact evaluation, and implementation monitoring.
- Managing incident / OOS / OOT investigations in coordination with cross-functional teams.
- Driving audit and inspection readiness , including preparation, documentation review, and compliance support during audits.
- Supporting regulatory inspections (USFDA / MHRA / internal audits) and ensuring timely response to observations.
- Reviewing and approving SOPs, protocols, reports, and quality documents as per document control procedures.
- Ensuring strict adherence to Good Documentation Practices (GDP) and data integrity (ALCOA+) principles .
- Monitoring and reviewing QMS metrics and trending for continuous improvement.
- Coordinating with Production, QC, and Engineering for closure of QMS events and documentation .
- Performing risk assessments (QRM tools like FMEA) for deviations, changes, and CAPA.
- Ensuring compliance with training systems , including SOP training and effectiveness evaluation.
- Managing document control activities , including issuance, revision, archival, and retrieval.
- Identifying system gaps and implementing continuous improvement initiatives in quality systems.
QA Senior Officer – QMS & Documentation
Intas Pharmaceuticals
10.2023 - 03.2025
- Managed and executed Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements.
- Handled deviation management , including investigation, root cause analysis (RCA), and closure with appropriate CAPA.
- Initiated and reviewed Corrective and Preventive Actions (CAPA) to ensure effectiveness and compliance.
- Managed change control system , including impact assessment, risk evaluation, and implementation tracking.
- Performed market complaint handling , investigation, and coordination with cross-functional teams for closure.
- Prepared and reviewed Annual Product Quality Review (APQR) / Product Quality Review (PQR) reports.
- Participated in internal audits and regulatory inspections , ensuring audit readiness and compliance.
- Maintained and controlled SOPs, specifications, and quality documents as per document control procedures.
- Ensured compliance with Good Documentation Practices (GDP) and data integrity (ALCOA+) principles .
- Reviewed batch documents, logbooks, and records for completeness and regulatory compliance.
- Coordinated with Production, QC, and Engineering for QMS-related investigations and documentation closure .
- Supported training management system , including SOP training and compliance tracking.
- Assisted in risk assessment activities (QRM) for deviations, change controls, and CAPA.
- Ensured proper document archival, retrieval, and version control as per QA procedures.
- Contributed to continuous improvement by identifying gaps in quality systems and suggesting corrective actions.
QA Officer – Documentation, BMR Review ,Validation
Acme Generics Private Limited
09.2022 - 09.2023
- Performed Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) review to ensure completeness, accuracy, and compliance with cGMP requirements.
- Identified and reported documentation errors, deviations, and discrepancies , ensuring timely correction and closure.
- Ensured compliance with Good Documentation Practices (GDP) during review and approval of records.
- Participated in audit readiness activities , including data verification, document retrieval, and compliance checks for internal and external audits.
- Supported regulatory and customer audits by preparing required QA documents and ensuring proper documentation control.
- Assisted in process validation activities , including review of validation protocols and reports (e.g., Process Validation, Cleaning Validation).
- Coordinated with Production and QC teams for clarifications during batch record review and ensured closure before final release.
- Reviewed and controlled SOPs (Standard Operating Procedures) , formats, and other quality system documents.
- Assisted in change control, deviation, and CAPA documentation , ensuring proper impact assessment and timely closure.
- Maintained and updated document control system including issuance, archival, and retrieval of controlled documents.
- Verified logbooks, equipment usage records, and calibration records for completeness and compliance.
- Ensured data integrity compliance (ALCOA+ principles) in all QA documentation activities.
- Participated in training programs related to GMP, GDP, and quality systems.
Junior Officer – QA
Macleods Pharmaceuticals
08.2019 - 08.2022
- Performed in-process quality checks during manufacturing activities such as granulation, compression, and coating.
- Monitored and verified line clearance before batch initiation to ensure absence of mix-ups and contamination.
- Reviewed and ensured compliance of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) .
- Conducted IPQA (In-Process Quality Assurance) activities on the production floor as per SOPs and cGMP guidelines.
- Verified dispensing of raw materials and ensured proper status labeling and documentation.
- Monitored environmental conditions (temperature, humidity, differential pressure) in production areas.
- Ensured adherence to Good Manufacturing Practices (cGMP) and data integrity principles .
- Performed in-process sampling and coordinated with QC for testing.
- Checked equipment cleaning and line status before and after batch operations.
- Assisted in deviation reporting, investigation, and closure .
- Supported change control and CAPA implementation activities.
- Ensured proper documentation practices (GDP) across production and QA records.
- Participated in internal audits and regulatory inspections readiness .
- Verified calibration status of instruments and equipment used in production.
- Coordinated with cross-functional teams (Production, QC, Engineering) to maintain product quality.
Education
Master of Pharmacy - Pharmaceutical Sciences
Uttarakhand Techanical University
Dehradun, India 04.2001 -
Bachelor of Pharmacy - Pharmaceutical Sciences
Dr A.P.J ABDUL KALAM TECHANICAL UNIVERSITY UTTAR PRADESH
Uttar Pradesh 04.2001 -
Skills
Work coordination
Team collaboration
Report writing
Emergency response coordination
Investigation leadership
Innovation and creativity
Self motivation
Strategic planning
Cultural awareness
Additional Information
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Date: __________
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Timeline
Senior Officer – QMS & Quality System
Sun Pharmaceutical Industries
03.2025 - Current
QA Senior Officer – QMS & Documentation
Intas Pharmaceuticals
10.2023 - 03.2025
QA Officer – Documentation, BMR Review ,Validation
Acme Generics Private Limited
09.2022 - 09.2023
Junior Officer – QA
Macleods Pharmaceuticals
08.2019 - 08.2022
Master of Pharmacy - Pharmaceutical Sciences
Uttarakhand Techanical University
04.2001 -
Bachelor of Pharmacy - Pharmaceutical Sciences
Dr A.P.J ABDUL KALAM TECHANICAL UNIVERSITY UTTAR PRADESH
04.2001 -