Hi, I’m
Sulabh Chaubey
Quality Assurance
Vejalpur, Ahmedabad,Gujarat
Work Preference
Summary
To enhance understanding of cGMP, GLP, data integrity, and laboratory compliance, analytical QA, audit readiness, and quality systems management. Highly accomplished and result-oriented Pharmaceutical Quality professional with 15+ years of progressive experience across Quality Assurance (Analytical QA), Quality Control (QC), GLP, and CQC functions. Extensive hands-on exposure in Sterile Injectable (Oncology) and Oral Solid Dosage (OSD) manufacturing facilities. Proven expertise in cGMP compliance, data integrity governance, laboratory compliance, regulatory inspections, and quality systems management. Actively involved in and successfully supported global regulatory audits including USFDA, MHRA, EMA, TGA, ANVISA, WHO, multiple customer audits, and Lachman Consultant audits.
Overview
16
years of professional experience
Work History
INTAS PHARMACEUTICALS LIMITEDAhmedabad, Gujarat
Assistant Manager
04.2023 - Current
Job overview
- Lead self-inspections, internal audits, and regulatory support activities.
- Perform comprehensive audit trail review and ensure compliance with data integrity principles.
- Audit of contract manufacturing organization (CMO) and vendor qualification.
- Involve in market complain investigation.
- Plan and manage analytical data review for QC laboratories.
- Review and approve QMS activities including Change Management, Deviations, OOS, LIR, CAPA adequacy and effectiveness.
- Review equipment and instrument qualification documents (URS/DQ/IQ/OQ/PQ).
- Conduct mock audits, identify gaps, and drive corrective and preventive actions.
- Ensure sustained GMP and GLP compliance through laboratory rounds and inspections.
- Review and control laboratory SOPs in alignment with regulatory and pharmacopeia requirements.
- Assess training and qualification status of laboratory personnel as per job roles.
- Review of Computer system validation (CSV) data.
TROIKAA PHARMACEUTICALS LIMITEDAhmedabad, Gujarat
Deputy Manager
04.2021 - 03.2023
Job overview
- Ensured end-to-end GMP and GLP compliance of QC laboratories.
- Supervised testing and release of raw materials, in-process samples, finished products, and stability samples.
- Managed QMS processes including Deviations, OOS, LIR, Change Management, CAPA, and RCA investigations.
- Led vendor qualification, external laboratory approvals, and service provider assessments.
- Reviewed instrument qualification (IQ/OQ/PQ) and working/reference standard qualification.
- Conducted internal audits and mock inspections and supported regulatory readiness.
- Identified training needs and ensured cGMP and data integrity training effectiveness.
ZYDUS PFIZER ONCOLOGY PVT. LTD.Ahmedabad, Gujarat
Asst. Manager
11.2016 - 03.2021
Job overview
- Planned and supervised GLP laboratory operations for oncology injectable.
- Ensured compliance with GMP and regulatory requirements.
- Reviewed audit trails, analytical data packages, calibration data, and Certificates of Analysis.
- Managed QMS documentation including SOPs, Change Controls, CAPAs, and effectiveness plans.
- Oversaw instrument qualification (URS, IQ, OQ, PQ).
- Led training, qualification, and job role mapping for new analysts.
- Maintained reference standards, impurities inventory, and working standards.
MYLAN LABORATORIES (SEZ)Indore , Madhya Pradesh
Senior Officer
05.2015 - 10.2016
Job overview
- Instrument calibration and qualification activities.
- Analytical data review and standard qualification.
- Logbook control and inventory management.
- Ensured compliance with GMP and internal quality systems.
RANBAXY LABORATORIES LIMITEDPaonta Sahib , Himanchal
Officer
07.2012 - 05.2015
Job overview
- Testing of incoming raw materials.
- Instrument calibration and qualification.
- Daily QC activity monitoring and GMP compliance.
KILITCH DRUGS (INDIA) LIMITEDPaonta sahib , Himanchal
Chemist
11.2010 - 04.2012
Job overview
- Sampling and testing of raw and packing materials.
- Routine QC analysis and documentation.
- Ensured compliance with SOPs and GMP standards.
Skills
Analytical Quality Assurance & Laboratory Compliance
cGMP, GLP & Data Integrity Assurance
Regulatory Inspection Readiness & Audit Support
Quality Management System (QMS)
OOS, Deviations, LIR Investigations & Root Cause Analysis
CAPA Management & Effectiveness Evaluation
Change Management & Risk Assessment’
Audit Trail Review (System & Analytical Data)
Equipment & Instrument Qualification (URS, DQ, IQ, OQ, PQ)
SOP Preparation, Review & Training Effectiveness
Reference & Working Standard Management
Laboratory Set-up & Contract Laboratory Audit
Compendial Assessment & Regulatory Observation Review
Strong regulatory mindset
Audit readiness & inspection handling
Analytical data review expertise
Team training & compliance leadership
Detail-oriented and quality-driven approach
Accomplishments
- Awarded as a star of month in Zydus Pfizer.
- Awarded as best internal auditor by Global Compliance Head in Intas Pharmaceutical Ltd.
- Awarded as Role Model in Intas Pharmaceutical Ltd.
DECLARATION
I hereby declare that the information provided above is true and correct to the best of my knowledge and belief. Place: Ahmedabad Name: Sulabh Chaubey Signature: __________________
REGULATORY & AUDIT EXPOSURE
- USFDA | MHRA | EMA | TGA | ANVISA | WHO
- Customer Audits | Lachman Consultant Audits.
Timeline
Assistant Manager
INTAS PHARMACEUTICALS LIMITED
04.2023 - Current
Deputy Manager
TROIKAA PHARMACEUTICALS LIMITED
04.2021 - 03.2023
Asst. Manager
ZYDUS PFIZER ONCOLOGY PVT. LTD.
11.2016 - 03.2021
Senior Officer
MYLAN LABORATORIES (SEZ)
05.2015 - 10.2016
Officer
RANBAXY LABORATORIES LIMITED
07.2012 - 05.2015
Chemist
KILITCH DRUGS (INDIA) LIMITED
11.2010 - 04.2012