2 - 5 years
3 - 5 Lacs
Posted:3 hours ago|
Platform:
Work from Office
Full Time
Job Summary: We are seeking a detail-oriented and process-driven Executive Engineering Documentation to manage and maintain engineering records and documentation related to equipment qualification, change control, and plant utilities. The ideal candidate should be well-versed with GMP documentation practices , engineering schedules , and technical drawing updates . Key Responsibilities: Prepare, review, and maintain equipment qualification documents (IQ/OQ/PQ). Assist in managing Change Control procedures related to equipment and utility modifications. Prepare and update logbooks, calibration schedules, preventive maintenance schedules , and related engineering records. Verify and maintain documentation for water systems, HVAC, and plant utilities in compliance with cGMP. Ensure timely updating and archival of engineering drawings (P&ID, GA, loop diagrams, etc.). Coordinate with validation, QA, and maintenance teams for document-related activities. Maintain compliance of documentation with regulatory expectations (USFDA, WHO, EU GMP, etc.). Support audit preparedness by ensuring document accuracy, traceability, and timely retrieval. Required Skills: Good knowledge of equipment qualification (IQ/OQ/PQ) and engineering documentation systems. Familiarity with change control management , document control procedures, and audit readiness. Proficiency in MS Office , AutoCAD (basic knowledge preferred) , and documentation tools. Strong communication, organizational, and record-keeping skills. Understanding of pharma utility systems like water plants, HVAC, and cleanroom equipment. Preferred Industry Experience: Pharmaceutical API or Formulations industry (mandatory)
MSN Group
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