Role & responsibilities: -

Quality Management System (QMS) Compliance -

- Deviation Management: Initiate, investigate, and close deviations related to mechanical equipment breakdowns, utility failures, and maintenance bypasses. Perform thorough Root Cause Analysis (RCA) using tools like Fishbone, 5 Whys, and FMEA.
- CAPA Implementation: Formulate and execute Corrective and Preventive Actions (CAPA) to eliminate the recurrence of mechanical failures and equipment-related compliance gaps.
- Change Control Management: Log, evaluate, and track Change Controls for any modifications, upgrades, or retrofitting of mechanical machinery, clean utilities, or HVAC systems.
- Risk Assessments: Conduct proactive and reactive Quality Risk Assessments (QRA) for mechanical maintenance activities and equipment modifications.

Documentation & SOP Lifecycle -

- SOP Authoring: Standardize engineering workflows by drafting, reviewing, and revising Standard Operating Procedures (SOPs) for mechanical maintenance, preventive schedules, and breakdown handling.
- Logbooks & Records: Review and maintain engineering logbooks, preventive maintenance (PM) checklists, and equipment history cards to ensure they are audit-ready at all times.
- Valuable Documentation Practices: Ensure the entire maintenance team follows GDP strictly during routine and breakdown tasks.





Sterile Maintenance Supervision (Excluding Calibration) -

- Aseptic Processing Equipment: Oversee the mechanical integrity and compliance of core injectables machinery including Vial Washers, Depyrogenation Tunnels, Liquid/Powder Fillers, Lyophilizers (Freeze Dryers), and Vial Sealing machines.
- Clean Utilities & HVAC: Monitor and maintain the compliance framework for pure steam generators, Water for Injection (WFI) generation/distribution loops, purified water systems, and sterile-grade HVAC systems.
- Preventive Maintenance (PM): Schedule, track, and document PM compliance to minimize unplanned downtime in critical cleanroom areas (Grade A to D).

Audit Readiness & Vendor Coordination -

- Regulatory Audits: Serve as a subject matter expert (SME) during external regulatory inspections (e.g., USFDA, MHRA) to defend engineering deviations, PM records, and QMS documentation.
- Vendor & Validation Liaison: Coordinate with equipment manufacturers for original spare parts and technical support, and collaborate with the Validation team during Re-qualification (IQ/OQ/PQ) phases post-major mechanical interventions.

Preferred candidate profile: -

- Required Experience: - 7 to 15 Years
- Required Qualification: - B.E. / B. Tech. / M.E. / M. Tech.

Regards,

Human Resources Management

Intas Pharmaceuticals SEZ Plant

📌 Job Opportunity For Sr. Executive / Asst. Manager - Engineering (QMS) (Bavla)
🏢 Intas
📍 Bavla