Open to opportunities

Tapas Kumar Bishoyi

@tapaskumarbishoyi

Senior GMP compliance and quality systems leader building audit-ready, data-integrity-first operations in regulated API pharma.

India

Message

What I'm looking for

I’m looking to lead GMP compliance and quality systems for regulated API manufacturing—owning audit-ready execution, robust change control/CAPA, data integrity (ALCOA/ALCOA++), and documentation & validation excellence, ideally with global relocation.

I’m a senior GMP compliance and quality systems leader with 15+ years of progressive impact in regulated API pharmaceutical manufacturing environments. I architect audit-ready operations and consistently deliver zero critical findings across stringent USFDA, WHO, and ANVISA regulatory inspections, with a strong focus on business continuity through data integrity.

I transform end-to-end compliance frameworks across Change Control, CAPA implementation, and Deviation/OOS/OOT governance, grounded in ICH-Q7 and cGMP documentation. I lead multi-disciplinary validation campaigns and embed strict Data Integrity (ALCOA/ALCOA++) standards, ensuring documentation governance for SOPs, BMRs, and validation protocols.

At J.B. Chemicals & Pharmaceuticals, I spearhead GMP documentation governance for a multi-product API site, achieve zero critical observations through proactive readiness, and drive measurable outcomes—like a 50% reduction in repeat deviation incidents. I govern 100+ SAP HANA manufacturing change controls annually, investigate 150+ deviations/OOS/OOT events, and maintain strong QMS performance across TrackWise, Documentum, and LIMS.

Experience

Work history, roles, and key accomplishments

Current

Assistant Manager - GMP

Current

J.B. Chemicals & Pharmaceuticals Ltd.

Sep 2021 - Present (4 years 9 months)

Spearheaded end-to-end GMP documentation governance and led audit-room readiness, achieving zero critical observations across USFDA, WHO, ANVISA, and customer audits. Governed change control (100+ SAP HANA changes annually) and reduced repeat deviation incidents by 50% through advanced root-cause analysis and verified CAPAs.

GMP Documentation Change Control CAPA Deviation OOS OOT Governance Audit Leadership Root Cause Analysis SAP Hana

Process Validation Executive

Zydus Lifesciences

Aug 2015 - Jun 2021 (5 years 10 months)

Managed complete GMP documentation lifecycle for a large-scale API facility, maintaining zero critical audit findings during WHO and USFDA inspections. Investigated 150+ deviations/OOS/OOT events and achieved a 100% CAPA acceptance rate while contributing to 10+ IQ/OQ/PQ campaigns.

Process Validation GMP Documentation CAPA Audit Readiness Regulatory Compliance Root Cause Analysis

GMP Compliance Officer

IPCA Laboratories Ltd.

Nov 2014 - Aug 2015 (9 months)

Maintained comprehensive production GMP documentation to sustain continuous cGMP compliance. Conducted SOP gap analyses, initiated deviation workflows, and streamlined OOS management processes.

GMP Documentation CGMP Compliance Deviation Management

Junior Officer - Operations

Glenmark Generics Ltd.

May 2011 - Nov 2014 (3 years 6 months)

Executed API batch manufacturing processes while adhering to GMP compliance standards in a regulated operational environment. Supported production execution with quality-focused compliance practices.

API Batch Manufacturing GMP Compliance CGMP Adherence Manufacturing Execution

Trainee Engineer - Production

Pan Drugs Ltd.

Jun 2010 - Apr 2011 (10 months)

Built foundational expertise in API production operations, equipment handling, and batch record documentation. Developed early GMP/cGMP compliance capability through training in regulated manufacturing practices.

Batch Record Documentation Training In ICH Q7 WHO GMP USFDA 21 CFR