Company · Leadership
The people behind the release
A batch is released by a person, not a process diagram. These are the functions that own each stage — from the fill line and the release panel to the dossier and the shipping case.
Rakesh Vaidya
Managing Director
An analytical chemist by training who spent his early career in contract testing before helping establish the Vadodara laboratory that became Ergopharm in 2005. He holds overall accountability for the site, its investment programme and the structural independence of the quality function from commercial pressure.
Anjali Deshmukh
Head of Quality Assurance / Qualified Person
More than twenty years in pharmaceutical quality systems across both sterile and oral solid dose operations, with deep experience of deviation investigation, CAPA effectiveness review and quality risk management under ICH Q9 and Q10. She is the site's release authority and owns the pharmaceutical quality system, the self-inspection programme and supplier qualification.
Sameer Iyengar
Head of Manufacturing
Two decades in sterile manufacturing, beginning as a filling-line operator and progressing through production supervision and aseptic process design. He runs the ampoule fill-finish suites and the oral solid dose facility, including gowning qualification, line-clearance discipline and the media-fill programme.
Priya Raghunathan
Head of Quality Control
A pharmaceutical analyst with eighteen years in regulated QC laboratories, specialising in separation science and in method validation to ICH Q2 principles. She is responsible for chemical, physical and microbiological testing to USP and Ph. Eur. monographs, laboratory data integrity under ALCOA+, and the ICH Q1A(R2) stability programme.
Martin Kessler
Head of Regulatory Affairs
Fifteen years in international regulatory affairs covering CTD dossier compilation, labelling and artwork control, and post-approval variations for export portfolios across several regions. He owns submission strategy, market-specific labelling requirements and the regulatory interface with our distributor partners.
Farhan Qureshi
Head of Export & Business Development
Nearly twenty years in pharmaceutical export, spanning distributor development, tender supply and shipping documentation under Incoterms 2020. He manages relationships with licensed distributors in more than forty markets and translates their technical and documentation requirements back into site planning.
Nilesh Barot
Head of Engineering & Utilities
A mechanical engineer with twenty-two years in GMP facility engineering, including water for injection and purified water systems, HVAC design for classified areas and clean utility qualification. He is accountable for utilities integrity, ISO 14644 environmental control, calibration, and the qualification and validation lifecycle under EU GMP Annex 15.
Functions on site
More than eight hundred people, in eight functions
Sterile Manufacturing (Fill-Finish)
≈210 peopleAseptic preparation, filling and sealing of the 13 ampoule presentations, applying EU GMP Annex 1 and PIC/S PE 009 principles — gowning qualification, line clearance, in-process control and routine media-fill process simulation.
Oral Solid Dose Manufacturing
≈180 peopleDispensing, granulation, blending, compression, coating and primary blister packing for the 14 tablet presentations, executed against approved batch manufacturing records.
Quality Assurance
≈95 peopleBatch record review and release, deviation and CAPA management, change control, supplier qualification, self-inspection and quality risk management under ICH Q9 and Q10.
Quality Control
≈120 peopleChemical, physical and microbiological testing to USP and Ph. Eur. monographs — HPLC, GC, dissolution, KF titration, sterility, bioburden and bacterial endotoxins — plus method validation and the ICH Q1A(R2) stability programme.
Engineering, Utilities & Validation
≈85 peopleWater for injection and purified water systems, HVAC and classified-area control to ISO 14644, clean steam and compressed gases, calibration, and the qualification and validation lifecycle aligned with EU GMP Annex 15.
Regulatory Affairs
≈40 peopleCTD dossier compilation and maintenance for export markets, artwork and multilingual labelling control, variation management and post-approval commitments, and pharmacovigilance liaison with distributor partners.
Supply Chain, Warehouse & Serialisation
≈110 peopleGDP-compliant receipt, quarantine, storage and dispatch; temperature mapping and cold-chain handling; and the serialisation platform — GS1 GTIN/SGTIN/SSCC coding, aggregation and EPCIS event exchange with trading partners.
Export & Business Development
≈35 peopleRelationships with licensed distributors in more than forty markets, tender and supply-agreement management, Incoterms 2020 shipping documentation, and technical liaison between customers and site functions.
Join them
We hire analysts, aseptic operators, validation engineers and regulatory staff throughout the year.