QMS Documentation Officer-Engineering

BIOALTUS; Vapi; On-site; INR 700,000 - 1,100,000; Full time

Job summary

BIOALTUS in Gujarat invites an Engineering professional to lead the documentation and maintenance program for critical facilities. You will prepare, maintain and control SOPs, formats, checklists and records, ensure GDP compliance, and keep audit-ready documentation across HVAC, water systems, PM schedules and calibration activities.

You will review SOPs, manage master document lists, track calibration due dates, and coordinate with QA/Engineering on discrepancies.

Qualifications

• Assist in ensuring GMP/ GDP alignment for documentation.

Responsibilities

• Prepare, maintain and control Engineering department SOPs, formats, checklists and records.
• Ensure timely review and revision of Engineering SOPs and controlled documents.
• Maintain Engineering document master lists and document issuance/withdrawal records.
• Ensure proper Good Documentation Practices (GDP) are followed.
• Maintain records in a traceable and audit-ready manner.
• Maintain Preventive Maintenance (PM) schedules and records.
• Review and track breakdown maintenance records.
• Ensure maintenance activities are documented and closed within defined timelines.
• Maintain equipment history cards/logbooks.
• Monitor pending maintenance documentation and follow up with Engineering personnel.
• Maintain calibration schedules for instruments and measuring devices.
• Track calibration due dates and ensure timely completion.
• Maintain calibration certificates and related records.
• Coordinate with QA/Engineering for calibration-related discrepancies and OOS/OOT conditions, where applicable.

Skills

HVAC systems

AHU

Chillers

Boilers

Compressors

DG/Power systems

Purified Water/WFI systems

ETP/STP

BMS/EMS

Cleanroom facilities

Job description

Role & responsibilities

• Prepare, maintain and control Engineering department SOPs, formats, checklists and records.
• Ensure timely review and revision of Engineering SOPs and controlled documents.
• Maintain Engineering document master lists and document issuance/withdrawal records.
• Ensure proper Good Documentation Practices (GDP) are followed.
• Maintain records in a traceable and audit-ready manner.
• Maintain Preventive Maintenance (PM) schedules and records.
• Review and track breakdown maintenance records.
• Ensure maintenance activities are documented and closed within defined timelines.
• Maintain equipment history cards/logbooks.
• Monitor pending maintenance documentation and follow up with Engineering personnel.
• Maintain calibration schedules for instruments and measuring devices.
• Track calibration due dates and ensure timely completion.
• Maintain calibration certificates and related records.
• Coordinate with QA/Engineering for calibration-related discrepancies and OOS/OOT conditions, where applicable.

Preferred candidate profile

• HVAC systems
• AHU
• Chillers
• Boilers
• Compressors
• DG/Power systems
• Purified Water/WFI systems, as applicable
• ETP/STP
• BMS/EMS
• Cleanroom facilities
• Critical utilities