Core Responsibilities1. Preventive & Breakdown Maintenance Logs
- Review, organize, and archive daily mechanical, electrical, and instrumentation maintenance logs.
- Compile and update Equipment History Files for heavy API machinery, including Glass-Lined Reactors, Centrifuges, Agitated Nutsche Filter Dryers (ANFD), and Micronizers.
- Verify completed Preventive Maintenance (PM) checklists against master schedules to ensure zero gaps in execution records.
2. SOP Creation & Lifecycle Management
- Write, revise, and update engineering department Standard Operating Procedures (SOPs) for process equipment and plant utilities.
- Coordinate with Process Engineers to integrate operational safety, cleanroom parameters, and lock-out/tag-out (LOTO) procedures into documentation.
- Manage the lifecycle of all technical specifications, ensuring engineering documents reflect actual current facility layouts and piping arrangements.
3. QMS, Deviations & CAPA Management
- Initiate and document engineering-related deviations, machinery breakdowns, and utility failures.
- Collaborate with technical teams to draft Corrective and Preventive Action (CAPA) plans based on detailed failure investigations.
- Prepare and track Engineering Change Control documentation for equipment modifications or new asset introductions.
4. Calibration & Validation Records
- Maintain a centralized registry for all critical manufacturing instrument calibration certificates.
- Draft and archive Equipment Qualification documents, including Installation Qualification (IQ) and Operational Qualification (OQ) reports.
- Maintain continuous tracking files for clean utilities like Purified Water (PW) systems, Compressed Air, Nitrogen, and HVAC systems.
5. Audit Readiness & Data Integrity
- Enforce ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) data integrity principles across all physical and electronic logs.
- Perform routine self-audits of the technical document room to identify and resolve record gaps before external regulatory inspections.
- Act as the primary point of contact for presenting engineering records during regulatory audits (e.g., USFDA, WHO, local state FDAs).
Pay: ₹332,027.25 - ₹620,665.88 per year
Benefits:
- Leave encashment
- Life insurance
- Provident Fund
Application Question(s):
- Mention your total experience
- Relevant experience in API
- Mention your current CTC
- Mention your expected CTC
- NOTICE PERIOD
- Current Location
Experience:
- Pharma API: 3 years (Preferred)
Work Location: In person
