Pharmaceutical QC Leader with 14+ Years Across Multi-Regulatory Facilities
Nirdesh Kumar Raghav is a seasoned Deputy Manager in Quality Control at Acme Generics' US FDA-approved facility in Baddi, Himachal Pradesh, with over 14 years of progressive pharmaceutical industry experience spanning Quality Control operations, regulatory compliance, and laboratory management. He functions as Designee of the Head of Department (General Block Quality Unit), reporting directly to the Cluster Head – Quality.
His career spans six pharmaceutical organisations — Acme Generics, Kusum Healthcare, Mankind Pharma, Ipca Laboratories, and Psychotropic India — giving him a comprehensive command of OSD (Tablets, Capsules), Liquids, Topical, Suspension, and Injectable dosage forms. He has successfully led his facilities through 1 US FDA inspection, 8 other regulatory inspections including Health Canada and EU-GMP, and 27 client audits with companies such as Merck, GSK, P&G, DRL, Biocon, Cipla, and Abbott — with zero major or critical observations.
He holds a Bachelor of Pharmacy from Gurukula Kangari University, Haridwar and is formally Approved as Analytical Chemist (Instrumental & Chemical) by the Licensing Authority and Drug Controller, Jaipur, Rajasthan (w.e.f. 02/12/2020). At DietXP, Nirdesh brings pharmaceutical precision and regulatory rigour to the review of supplement, clinical nutrition, and health science content.
Areas of Expertise
Inspection & Audit Excellence
Regulatory Bodies
Select Client Auditors
Merck · P&G · GSK · JAMP · DRL · Biocon · Rubicon · Intas · Alkem · Cipla · Glenmark · Pinnacle · Aristo UK · Zydus · Strides · SUN · Viatris · Mankind Pharma · Abbott · Torrent Pharma
Nirdesh's unblemished audit record — spanning global Big Pharma clients and multiple health authorities — reflects a consistent commitment to GMP compliance, meticulous documentation, and proactive quality systems management.
Professional Journey
Deputy Manager — General Block, Quality Control
Acme Generics US FDA Approved Facility, Baddi, Himachal Pradesh
August 2024 — Present
Functioning as Designee of HOD – General Block Quality Unit, reporting to Cluster Head Quality. Leads routine QC for OSD (Tablets, Capsules) and oversees qualification of new projects. Responsible for life cycle management of products, lab instruments, and related software; planning & monitoring of operational and capital budgets; and site lead for LIMS advancement integrated with QC instruments. Maintaining compliance with 21 CFR Part 11 across a multi-regulatory CMO facility. Responsible for implementing quality systems including SAP, LIMS, LMS, Clean, Ample Logic, Lab Solutions, eLog, EDCS. Leads internal and external audit programs. Successfully cleared Health Canada Audit and EU-GMP Audit 2025 with no major or critical observations.
Deputy Manager — Quality Control
Kusum Healthcare Pvt. Ltd., Bhiwadi, Rajasthan
April 2017 — August 2024 (7+ years)
Led routine QC laboratory for OSD (Tablets, Capsules), Liquids, Topical formulations (Ointments, Cream, Gel, Shampoo) and Suppositories. Served as Group Leader for Finished Products & Metrology, and previously for Raw Material, Packing Material, Cleaning Validation and AMV/Method Remediations. Responsible for usage decisions across FP, IP, HTS, RM, PM, Calibrations, and Qualifications. Implemented Caliber LIMS, Caliber QMS, Ample Logic, SAP, Empower 3, and Lab Solution Software.
Officer — Quality Control
Mankind Pharma Ltd. Unit-2, Paonta Sahib, Himachal Pradesh
June 2015 — April 2017
Oversaw routine planning for Finished Goods analysis, in-process and Process Validation samples for OSD, Liquid, and Soft Gel dosage forms. Incharge of all laboratory incident investigations (LIR, OOS, OOT). Managed Change Controls for exhibit stability protocols and testing monographs. Adhered to cGMP (PIC/S guidelines) for documentation. Filed incidents through SAP.
Officer — Quality Control
Ipca Laboratories Ltd., Dehradun
August 2014 — June 2015
Performed qualitative and quantitative analysis of finished products, stability samples, and raw materials per Eur Ph., IP, and BP pharmacopeias, for OSD and Injectable dosage forms. Conducted Cleaning Validation and water sample analysis. Deployed analytical techniques including HPLC, GC Headspace, UV, FTIR, Dissolution, and Titration using Empower and Lab Solution software.
Officer — Quality Control
Kusum Healthcare Pvt. Ltd., Bhiwadi, Rajasthan
February 2013 — July 2014
Analysis of raw materials for OSD, Liquid, and Topical products using HPLC, GC, UV, Dissolution, DT Polarimeter, Refractive Index, and FTIR. Worked on Method Validation. Maintained GLP/GCP standards and detailed analytical records. Performed instrument quality checks and pipette calibration.
Junior Officer — Quality Control
Psychotropic India Ltd., Haridwar, Uttarakhand
August 2011 — February 2013
Sampling & analysis of raw and packing materials. Chemical and UV-Spectrophotometer analysis of bulk samples and finished products for OSD and Injectables. Preparation & standardisation of volumetric solutions. Daily verification of analytical balances and calibration of pH meter. Maintained GLP/GCP standards throughout.
Academic Qualifications
Bachelor of Pharmacy (B.Pharm)
Gurukula Kangari University, Haridwar
Board of High School & Intermediate Education
Board of High School & Intermediate Education, Uttar Pradesh
Board of High School & Intermediate Education
Board of High School & Intermediate Education, Uttar Pradesh
Awards & Honours
Mountain Movers — Outstanding Team Award
Recognised for exceptional team performance and leadership, contributing to Acme Generics' regulatory and operational excellence in the General Block Quality Unit.
Star of the Month
Individual recognition for outstanding contribution to quality operations and regulatory readiness at Acme Generics' Baddi facility.
First Prize — Safety Quiz Competition
Won first prize at the Safety Quiz Competition organised during the 54th National Safety Week at Acme Generics Pvt. Ltd., reflecting deep commitment to workplace safety.
Two-Time Safety Quiz First Prize Winner
Achieved first prize at the Safety Quiz Competition in both the 50th (2021) and 53rd (2024) National Safety Weeks at Kusum Healthcare Pvt. Ltd.
Certificate of Appreciation — Exemplary Performance
Recognised for exemplary performance in the Kusum Healthcare Employee Wellness Program for the period August–September 2020.
Approved Analytical Chemist — Instrumental & Chemical
Formally approved as Analytical Chemist (Instrumental & Chemical) w.e.f. 02/12/2020 by the Licensing Authority and Drug Controller, Jaipur, Rajasthan.
IT & Analytical Skills
Analytical Instruments & Techniques
Quality & Laboratory Software
Regulatory & QMS Expertise