Key Responsibilities
- GMP Documentation & Records: Maintain, organize, and archive all technical documents, including equipment drawings, P&IDs (Piping and Instrumentation Diagrams), and vendor manuals.
- Equipment History Management: Create and maintain equipment files, histories, and logs for API production machinery (e.g., reactors, centrifuges, dryers, cleanroom HVAC).
- Calibration & Maintenance Documentation: Prepare, review, and execute documentation related to Instrument Calibration and Preventive Maintenance (PM) schedules.
- Validation Support (DQ/IQ/OQ/PQ): Assist in preparing and documenting equipment qualifications (Design, Installation, Operational, and Performance Qualifications).
- QMS Documentation (CAPA/Change Control): Handle documentation for Quality Management Systems (QMS), including Change Controls, Corrective and Preventive Actions (CAPA), and deviations.
- SOP Development: Draft, review, and update Standard Operating Procedures (SOPs) for mechanical maintenance and utility operations.
- Audit Readiness: Ensure 100% compliance with documentation standards for internal and external audits
Candidate Profile
- Education: Diploma in Mechanical Engineering (DME) or related field.
- Technical Knowledge: Basic understanding of mechanical equipment, HVAC systems, and piping systems used in chemical or pharma plants.
- Skills: Proficiency in MS Office (Word, Excel) for creating reports.
- Key Traits: High attention to detail, strong organizational skills, and good technical writing abilities.
Pay: ₹12,813.75 - ₹18,405.43 per month
Benefits:
- Health insurance
- Leave encashment
- Paid sick time
- Provident Fund
Application Question(s):
- your current location ?
- Are you fresher ?
- If selected how soon you can join ?
Location:
- Vapi, Gujarat (Vapi, Valsad District) (Required)
Work Location: In person
