Summary
Overview
Work History
Education
Skills
Languages
Projects
Custom Section
Timeline
Generic
Purnendu Shekhar Singh

Purnendu Shekhar Singh

Jaunpur

Summary

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 investigation quality improvement (Through RCA, Effective CAPA, Repeat Incident Analysis).
  • 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
  • Training on Data integrity, Validant consulting
  • Deviation management, Mr. Sarang Athawale
  • Root cause analysis, Lachman consultants

Timeline

Sr.Manager Internal Audit And Compliance

Eugia Pharma specialities Limited
12.2025 - Current

QA Manager

Zydus life sciences (Alidac, SEZ)
03.2023 - 11.2025

IPQA In-charge

Dr. Reddys Labs
10.2022 - 03.2023

QMS Incharge

Dr. Reddys Labs
01.2020 - 09.2022

Asst.Manager

Alembic pharmaceuticals Ltd.
03.2018 - 01.2020

Asst.Manager

Cadila pharmaceuticals Ltd.
01.2012 - 03.2018

Sr.officer

Alkem labs. Ltd.
03.2008 - 01.2012

B.Pharma -

RGHUS University
Purnendu Shekhar Singh