Mr. Bhupinder Singh

Mr. Bhupinder Singh

EXECUTIVE SUMMARY

A results-oriented pharmaceutical professional with a proven track record of enhancing quality systems, improving operational efficiency, and contributing to organizational growth. Possess 35+ years of experience in Quality Control, Quality Assurance, Validations, and Compliance across sterile & non-sterile dosage forms, biologicals, SVPs & LVPs, sterile APIs, MDI, ophthalmic, nasal sprays, and dialysis solutions. Over 20 years at senior management (Head-QA/QC).

Key Highlights

  • Set up Quality Management Systems in multiple greenfield pharma manufacturing projects.

  • Transformed domestic facilities to meet highly regulated international market standards.

  • Successfully hosted regulatory inspections: USFDA, EU-GMP, WHO-PQ, TGA (Australia), ANVISA (Brazil), etc.

  • Conducted 100+ audits of drug substances, drug products & packaging material vendors in India & overseas.

POSSESSES EXPERTISE IN THE FOLLOWING AREAS

  • Auditing, remediation, compliance & data integrity

  • Investigations, Root Cause Analysis & CAPA implementation

  • Effective implementation of Quality Management Systems

  • GLP: Data Integrity, OOS/OOT investigations, lab incidents, instrument qualification, stability studies, SOP/specification review, analytical method validation, reference standard qualification

  • Microbiology: Environmental & water monitoring, sterility, BET, MLT validation, disinfectant efficacy validation, PET validation

  • Aseptic Processing: Media fill, sterile APIs, sterile dosage forms

  • Process validation of solid & liquid oral dosage forms

  • Cleaning validation

  • Facility & equipment qualification (sterile + oral facilities)

  • Utility qualification: HVAC, water system, pure steam, compressed gases

CAREER OVERVIEW

  • BSG Pharmaconsult (Freelance Consultant) – Jan 2024 onwards

  • Nichepharma Lifesciences Pvt. Ltd., Dehradun – Director-Technical (2023–2024)

  • Acme Group, Nalagarh (HP) – Chief Quality Officer (2022–2023)

  • Square Pharmaceuticals Ltd., Dhaka – VP-QA (Head QA/QC) (2021–2022)

  • Alkem Laboratories Ltd., Baddi – VP-Quality (2012–2021)

  • Torrent Pharmaceuticals Ltd., Baddi & Sikkim – General Manager-QA (2004–2012)

  • Unichem Laboratories Ltd., Baddi – Senior Manager-QA/QC (2001–2004)

  • Lupin Ltd., Bhopal – Manager-Microbiology (1990–2001)

  • Amrit Protein Foods Ltd., Ghaziabad – Microbiologist (1989–1990)

  • Unichem Laboratories Ltd., Ghaziabad – Jr. Analyst (1988–1989)

PROFESSIONAL DEVELOPMENT

  • Worked with international consultants: Lachman, PharmaConsult US, SGS

  • Training on Good Auditing Practices – Quality Council of India

  • Development programs in technical, team building & leadership areas:

    • IIM Ahmedabad

    • Stephen Covey – 7 Habits

    • Dale Carnegie – Train the Trainer

    • ISO 9001:2000, ISO 14000

  • Taught Pharmaceutical Quality Systems to M.Pharm students (NIPER Mohali, UIPS Chandigarh)

  • Attended national & international workshops & seminars

  • Member of ISPE, PHSS

PROFESSIONAL EXPERIENCE

Nichepharma Lifesciences Pvt. Ltd., Dehradun – Director-Technical (2023–2024)

Responsibilities:

  • Technology Transfer, Quality & Compliance

  • QMS implementation, GMP audits, self-inspections, risk/gap analysis, training

  • Regulatory response preparation & CAPA

  • Qualification & validation strategy, VMP, sterility assurance, cleaning & process validation

  • Media fills, APRs, statistical process analysis, investigations

  • Training: GMP, Compliance, QMS, Aseptic Processing, Environmental Monitoring

  • Design & Engineering: URS, FAT, maintenance, calibration plans

  • Risk assessment for deviations, change controls & impurity risks

  • Mentored team for upcoming EU-GMP & other inspections

Acme Group, Nalagarh (HP) – Chief Quality Officer (2022–2023)

Led a team of 500 quality personnel across 3 EU-GMP & USFDA-approved facilities.

Key Achievements:

  • Successfully hosted USFDA inspections twice (2022 & 2023)

  • Hosted EU-GMP inspection for all 3 facilities

  • Achieved WHO-Prequalification approval for Hormone block

Square Pharmaceuticals Ltd., Dhaka – Vice President-QA (2021–2022)

Headed Quality & Compliance for Bangladesh’s No.1 pharmaceutical company.

Team size: 600+ (QA, QC, Microbiology, Validations, Calibrations, Compliance)

Alkem Laboratories Ltd., Baddi – VP-Quality (2012–2021)

Managed QA/QC across multiple functional blocks catering to US, EU, UK, Australia & other regulated markets.

Key Achievements:

  • Hosted USFDA inspections 9 times

  • Hosted EU-GMP/MHRA 5 times

  • Cleared inspections by TGA, ANVISA, INVIMA, SAHPRA & others

Torrent Pharmaceuticals Ltd. – General Manager-QA (2004–2012)

Responsibilities included QMS implementation, resource planning, investigations, CAPA, internal/external audits & MIS reporting.

Unichem Laboratories Ltd. – Senior Manager QA/QC (2001–2004)

Key Achievement: Successfully hosted MHRA inspection for OSD facility.

Lupin Limited – Manager Microbiology (1990–2001)

Handled: Environmental monitoring, BET, sterility, media fills, validation, vendor audits & more.

Key Achievement: Successful USFDA & MHRA approvals for APIs & injectables.

ACADEMIC / PROFESSIONAL QUALIFICATIONS

  • M.Sc. Microbiology (Biochemistry Minor) – GBPUAT, Pantnagar

  • MBA (Operations Management) – IGNOU, New Delhi

SERVICES OFFERED AS CONSULTANT

  • Mock audits & gap assessments for US/EU/WHO-PQ/PIC-S

  • Annex-1 & CCS gap assessment

  • Remediation of regulatory audit observations

  • Smoke study review

  • Vendor audits (APIs, excipients, DP, packaging)

  • Environmental monitoring program design

  • GMP & Microbiology training

  • SOPs, policies, standards preparation

  • Validation protocol preparation & report review

CONTACT DETAILS

Email: bsgpharmaconsult@gmail.com