Company Overview Prism Industrial Systems (formerly Prism Pharma Machinery) is one of India's leading manufacturers of process equipment for the pharmaceutical, nutraceutical, food, and beauty products industries, headquartered in Ahmedabad, Gujarat. Established in 2004, the company designs, manufactures, and exports a comprehensive range of process equipment with over 1,000 machines installed across 65+ countries. Operating from a 10,000 m² manufacturing facility, Prism Industrial Systems serves 800+ global clients with solutions spanning granulation, drying, mixing, milling, tabletting, coating, pelletizing, material conveying, CIP/WIP washing systems, and process automation.
The QA/QC Manager is responsible for leading the quality function at Prism Industrial Systems, ensuring that all manufacturing equipment (granulators, tablet presses, filling lines, isolators, and allied process machinery) is designed, fabricated, assembled, and tested in strict compliance with global regulatory standards, including FDA cGMP, GAMP 5, 21 CFR Part 11, and EU Annex 11, as well as the company's ISO 9001 Quality Management System.
This role bridges heavy mechanical and electrical engineering with the highly documented compliance requirements of the pharmaceutical, food, and FMCG machinery industry, ensuring flawless execution of Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and Equipment Validation (DQ/IQ/OQ). The ideal candidate combines a meticulous, standards-driven approach with the confidence to defend quality decisions to production teams, senior management, and demanding international clients.
Regulatory Compliance & Quality Systems
Ensure all machinery design, automation (PLC/SCADA), and manufacturing processes adhere to cGMP, GAMP 5, FDA regulations, and EU Annex 11 requirements.
Own, implement, and continuously improve the company's Quality Management System (QMS) in line with ISO 9001, with ISO 13485 alignment where applicable.
Translate customer-specific quality requirements and User Requirement Specifications (URS) into internal quality standards and inspection plans.
Oversee the compilation, execution, and approval of Equipment Qualification protocols (DQ, IQ, OQ) for all manufactured equipment.
Ensure 100% traceability from the customer's URS through design, fabrication, and final qualification documentation.
Coordinate with Design and Automation teams to ensure validation protocols reflect actual equipment configuration and functionality.
Audits,



Inspections & Risk Management
Lead all external audits from global pharmaceutical, food, and FMCG clients, ISO registrars, and regulatory bodies, acting as the primary technical quality contact.
Facilitate Quality Risk Management (QRM) and Failure Mode and Effects Analysis (FMEA) during design and process planning phases.
Coordinate third-party inspection agency visits (TUV, Bureau Veritas, SGS, Lloyd's) and manage closure of resulting observations.
Shop Floor Quality Control & Inspection
Manage the QC inspection team across incoming material inspection, in-process fabrication checks (welding, surface roughness/Ra testing), and final assembly inspection.
Ensure all manufactured equipment meets pharmaceutical-grade surface finish standards, dimensional tolerances, and documentation requirements.
Drive continuous improvement in inspection methods to reduce rework, scrap, and post-delivery modifications.
Oversee and sign off on Factory Acceptance Testing (FAT), ensuring first-time-right execution ahead of customer witness testing.
Support customers during Site Acceptance Testing (SAT) at installation locations, resolving on-site quality queries.
Coordinate pre-dispatch inspection and export documentation to ensure equipment readiness for shipment across international markets.
Software, Data Integrity & Automation Validation
Review PLC, SCADA, and HMI validation protocols in coordination with the Automation and Design teams.
Ensure data integrity principles (ALCOA+) are embedded across all quality documentation, both physical and electronic.
Supplier & Vendor Quality Management
Manage the vendor qualification programme for critical bought-out components, including valves, pumps, PLCs, sensors, and instrumentation.
Work with Procurement to build a reliable, quality-assured vendor base for sub-contracted processes such as precision machining and specialised welding.
Lead, mentor, and develop the QA/QC team, including inspectors, documentation specialists, and shop floor quality personnel.
Build a culture of quality ownership, attention to detail,



and accountability across the manufacturing organisation.
Deliver structured training on cGMP awareness, inspection techniques, and documentation discipline for shop floor and quality staff.
Present monthly quality performance review to the Plant Head and senior management, covering audit outcomes, CAPA status, and key quality metrics.

Key Performance Indicators (KPIs)
Audit Performance: zero critical or major non-conformances during client and regulatory audits.
Cost of Poor Quality (COPQ): continuous reduction in scrap, rework hours, and post-delivery modifications.

Experience
~8 to 12 years of total experience in QA/QC within an engineering or machinery manufacturing setup.
~ Minimum 3 to 5 years in a leadership or managerial role, explicitly producing equipment for the pharmaceutical, food, FMCG, or medical device industry.
~ Demonstrated experience managing FAT/SAT execution, equipment validation, and customer or regulatory audits.

Bachelor's degree in Science, Mechanical Engineering, Electrical/Automation Engineering, Instrumentation, or a related technical discipline.
Certification in Quality Management (e.g., Expertise in metal fabrication quality standards, including ASME BPE for bioprocessing equipment, welding qualifications, and boroscopy inspection.
Strong familiarity with PLC, SCADA, and HMI validation protocols.
Experience implementing and maintaining ISO 9001, with ISO 13485 as a plus.
Working knowledge of CAD drawings sufficient to cross-check inspection results against engineering specifications.
Assertive communication, with the ability to confidently defend quality standards to internal production teams and strict pharmaceutical clients.
Strong stakeholder management skills for reporting to the Plant Head and engaging cross-functionally with Design, Production, and Sales.
Prior experience in an Ahmedabad / Gujarat-based manufacturing setting with familiarity with the local vendor and testing ecosystem.
Experience working with international pharmaceutical, food, or FMCG companies, EPC contractors, or OEM customers who conduct factory audits and FAT inspections.
Exposure to process automation, PLC/SCADA integration, and Industry 4.0 concepts as they relate to equipment validation and digital quality records.
Track record of reducing COPQ and improving FAT first-time-right rates through structured quality initiatives.
Phone: +91 6282-377780
Website:

📌 Quality Assurance / Control Supervisor (Permanent) (Ahmedabad)
🏢 Nvistra Human Capital Advisory
📍 Ahmedabad