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Rajesh Kumar

@rajeshkumar34

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Project Manager at PQE Group leading CSV and CQV compliance for GxP systems and training readiness.

India

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At PQE Group, I lead quality compliance, training readiness, audit preparation, and validation activities for GxP computerized systems. I review SOPs and validation documents, support inspection readiness, and provide QA oversight aligned with 21 CFR Part 11, Annex 11, and GAMP 5.

Across roles at Curia Global, Akorn Private Limited, Mylan Laboratories Limited, Macleods Pharmaceuticals Limited, and Dr. Reddy’s Laboratories Limited, I’ve worked across microbiology QA, laboratory compliance, and CSV/CQV. My work has included training governance, audit and CAPA management, investigations, and laboratory equipment qualification; at Mylan, I supported a project to simplify and harmonize more than 100 microbiology laboratory SOPs.

Experience

Work history, roles, and key accomplishments

Current

Project Manager

Current

PQE Group

Oct 2025 - Present (1 year)

Lead Quality Compliance, Training Readiness, Audit Preparation, and Validation activities for GxP computerized systems. Ensure training completion and effectiveness for QA/QC personnel through LMS tracking and role-based curricula.

CSV CQV GxP 21 CFR Part 11 Annex 11 Regulations GAMP 5 Best Practices LMS SOPs CAPA Deviation Management Change Control Internal Audit Regulatory Inspections Quality Oversight Training Oversight Risk Management

Senior Manager – Operations Excellence

Curia Global

Aug 2024 - Oct 2025 (1 year 2 months)

Owned training compliance framework, including Department Training Plan Matrix, SOP training, and effectiveness checks. Led internal audits, managed CAPA lifecycle, and ensured alignment of validation activities with GxP regulations.

Training and Compliance Governance SOPs Internal Audit CAPA Risk Assessment Deviation Management Change Control Validation GxP CQMS Documentum LMS

Project Manager – CSV & CQV Compliance

PQE Group

Jun 2020 - Aug 2024 (4 years 2 months)

Managed CSV and CQV compliance projects, including establishment of new Microbiology Laboratory with regulatory compliance. Supported training delivery, audit readiness, and QA review of deviations and CAPAs.

CSV CQV Microbiology Equipment Qualification URS Data Quality IQ+SOPs Training Audit Readiness Data Integrity CAPA Deviation Management

Assistant Manager – Microbiology

Akorn Private Limited

May 2016 - Feb 2020 (3 years 9 months)

Acted as Laboratory QA Lead for microbiology, supporting cGMP, GLP, and data integrity compliance. Reviewed and approved deviations, OOS, investigations, CAPA, and change controls.

Microbiology GMP GLP Data Integrity CAPA Deviation Management OOS OOT Change Control Training Equipment Qualification CSV Audit Trail Review OPEX CAPEX Budgeting

Senior Executive – Microbiology

Mylan Laboratories Limited

Aug 2015 - Apr 2016 (8 months)

Performed QA review of analytical data, SOPs, calibration records, and validation documents. Conducted training on laboratory procedures, GLP, and aseptic techniques.

Microbiology QA Review SOPs GLP Aseptic Technique Training Documentum CAPA Internal Audit Regulatory Inspections

Section In-Charge – Microbiology

Macleods Pharmaceuticals Limited

May 2013 - Aug 2015 (2 years 3 months)

Worked as Lab in Charge-Microbiology, conducting microbiology studies as per plan and schedule. Handled investigations, OOS, OOT, deviations, and supervised laboratory compliance and CAPA implementation.

Microbiology OOS OOT Deviation Management CAPA SOP Management training coordination Equipment Qualification Validation Protocols

Junior Manager – Microbiology & IPQA

Dr. Reddy’s Laboratories Limited

Jan 2006 - Apr 2013 (7 years 3 months)

Managed EM programs, water systems, laboratory investigations, and QA documentation. Conducted risk assessments, SOP reviews, and supported multiple regulatory inspections and internal audits.