QA/QC Manager

Nvistra Human Capital Advisory · Ahmedabad, India

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.

Role Summary

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.

Key Responsibilities

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.

Validation & Equipment Qualification

• 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.

Documentation & Turn Over Package (TOP)

• Champion the timely and error-free delivery of the Turn Over Package (TOP) for every equipment dispatch.
• Guarantee that all material certificates (including 316L stainless steel MTRs and USP Class VI certification for gaskets) and weld logs are complete and accurate.
• Maintain a document control system ensuring version integrity of drawings, protocols, and inspection records.

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.
• Own the CAPA (Corrective and Preventive Action) system, driving root-cause analysis for deviations and ensuring zero repeat errors.
• 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.

FAT, SAT & Customer Acceptance

• 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

• Verify that automated systems, electronic records, and audit trails comply with 21 CFR Part 11 requirements.
• 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.
• Audit suppliers of critical parts to ensure engineering integrity, and drive corrective action where non-conformances are identified.
• Work with Procurement to build a reliable, quality-assured vendor base for sub-contracted processes such as precision machining and specialised welding.

Team Leadership & Continuous Improvement

• 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)

• FAT First-Time-Right (FTR) Rate:  achieve greater than 95% success rate during customer FATs.
• Audit Performance:  zero critical or major non-conformances during client and regulatory audits.
• Documentation Accuracy:  100% error-free Turn Over Packages (TOP) delivered on time.
• CAPA Velocity:  average closure of deviations and corrective actions within 30 days.
• Cost of Poor Quality (COPQ):  continuous reduction in scrap, rework hours, and post-delivery modifications.

Qualifications & Requirements

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.

Education

• Bachelor's degree in Science, Mechanical Engineering, Electrical/Automation Engineering, Instrumentation, or a related technical discipline.
• Certification in Quality Management (e.g., ASQ CQE/CMQ-OE) or Six Sigma Green Belt/Black Belt is recommended.

Technical Skills

• Deep understanding of cGMP, GAMP 5, 21 CFR Part 11, and EU Annex 11.
• 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.

Core Competencies

• Meticulous eye for detail, able to spot discrepancies between engineering blueprints, URS, and final documentation.
• Assertive communication, with the ability to confidently defend quality standards to internal production teams and strict pharmaceutical clients.
• Expert in root-cause problem-solving tools, including Fishbone diagrams, 5-Whys, and FMEA.
• Strong stakeholder management skills for reporting to the Plant Head and engaging cross-functionally with Design, Production, and Sales.
• High standards for documentation discipline, traceability, and audit readiness at all times.
• Ability to manage multiple concurrent FAT/SAT schedules and audit commitments under tight export delivery deadlines.

Preferred Attributes

• Prior experience in an Ahmedabad / Gujarat-based manufacturing environment 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.
• Knowledge of PESO (Petroleum and Explosives Safety Organisation) and CCOE regulations for pressure vessels and equipment operating under pressure or vacuum.
• Track record of reducing COPQ and improving FAT first-time-right rates through structured quality initiatives.

Contact Details

Contact:  Neethu Narambrath

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