Job Description – QA Engineer
Job Title: Quality Assurance (QA) Engineer
Department: Quality Assurance
Location: Pune, Maharashtra
Industry: Pharmaceutical Equipment Manufacturing
Experience: 2–3 Years
Female candidates are encouraged to apply.
Qualification
- B.E./B.Tech/Diploma in Mechanical Engineering, Production Engineering, or Industrial Engineering.
- Certification in Quality Management Systems (ISO 9001) will be an added advantage.
Job Summary
The QA Engineer is responsible for ensuring that pharmaceutical process equipment is manufactured in accordance with customer specifications, GMP requirements, ASME standards, and the company's Quality Management System (QMS). The role involves implementing quality assurance processes, maintaining quality documentation, coordinating inspections and audits, supporting Factory Acceptance Tests (FAT), and driving continuous improvement to ensure defect-free products and customer satisfaction.
Key Responsibilities
Quality Assurance
- Develop, implement, and maintain Quality Assurance procedures throughout the manufacturing process.
- Ensure compliance with ISO 9001, GMP, customer specifications, and company quality standards.
- Review engineering drawings, technical specifications, and Quality Plans before production.
- Monitor manufacturing activities to ensure adherence to approved quality procedures.
- Conduct in-process quality inspections and final product verification.
- Prepare and review Inspection & Test Plans (ITP), Quality Assurance Plans (QAP), and quality checklists.
Inspection & Testing
- Coordinate dimensional, visual, and functional inspections of fabricated and assembled equipment.
- Verify material traceability and inspection records.
- Witness hydrostatic, pneumatic, pressure, leak, and functional testing.
- Coordinate Factory Acceptance Tests (FAT) with customers and internal departments.
- Ensure inspection and testing activities comply with project specifications and applicable standards.
Documentation
- Prepare and maintain Manufacturing Record Books (MRB), Data Books, Quality Dossiers, and final documentation packages.
- Review Mill Test Certificates (MTCs), calibration certificates, welding qualifications (WPS, PQR & WPQ), inspection reports, and test records.
- Maintain Non-Conformance Reports (NCRs), Corrective & Preventive Actions (CAPA), and deviation records.
- Ensure complete quality documentation is available prior to equipment dispatch.
Supplier & Process Quality
- Perform incoming material inspections and supplier quality evaluations.
- Coordinate with vendors to resolve quality-related issues.
- Participate in supplier audits and vendor qualification activities.
- Monitor corrective actions and ensure timely closure of quality observations.
Continuous Improvement
- Investigate quality issues and perform root cause analysis using standard quality tools.
- Recommend process improvements to reduce defects and improve product quality.
- Participate in internal quality audits and Management Review Meetings.
- Support implementation of Lean Manufacturing, 5S, and Continuous Improvement initiatives.
Customer & Project Support
- Participate in customer inspections and third-party audits.
- Coordinate with Production, Design, Projects, Procurement, and Service departments.
- Address customer quality concerns and ensure timely resolution.
- Support installation and commissioning teams with quality-related documentation whenever required.
Required Skills
- Strong knowledge of fabrication, machining, welding, polishing, and mechanical assembly inspection.
- Ability to read and interpret engineering drawings, fabrication drawings, P&IDs, and General Arrangement (GA) drawings.
- Knowledge of stainless steel (SS304 & SS316L) fabrication and pharmaceutical equipment manufacturing.
- Familiarity with GMP, ISO 9001, ASME standards, and pharmaceutical quality documentation.
- Understanding of welding inspection, sanitary surface finish requirements, and pressure testing.
- Hands-on experience with precision measuring instruments including:
- Vernier Caliper
- Micrometer
- Height Gauge
- Dial Indicator
- Bore Gauge
- Surface Roughness Tester (preferred)
- Excellent documentation and report-writing skills.
- Proficiency in Microsoft Office applications; ERP knowledge is an added advantage.
Preferred Experience
- Quality Assurance in pharmaceutical process equipment manufacturing.
- Preparation of FAT documentation, Quality Dossiers, and Validation Documentation.
- Handling customer inspections, third-party inspections, and supplier audits.
- Experience with GMP and clean process equipment manufacturing.
Equipment Exposure
Experience with inspection and quality assurance of the following equipment will be preferred:
- Autoclaves (Steam Sterilizers)
- Bung Processors
- Superheated Water Spray Sterilizers
- Multi Column Distillation Plants (MCDP) / WFI Plants
- Pure Steam Generators (PSG)
- Sterile Process Vessels
- Ointment Manufacturing Plants
- Liquid Manufacturing Plants
- Fluid Bed Dryers (FBD)
- Rapid Mixer Granulators (RMG)
- Vacuum Conveying Systems
- CIP/SIP Systems
- Process Skids
- Fermenters
Key Competencies
- Quality Assurance & Compliance
- Technical Documentation
- Analytical & Problem-Solving Skills
- Attention to Detail
- Communication & Coordination
- Customer Focus
- Teamwork
- Time Management
- Continuous Improvement Mindset
- Commitment to GMP and Quality Standards
Pay: ₹20,000.00 - ₹30,000.00 per month
Benefits:
Work Location: In person
