Senior Executive QMS Maintenance & Engineering

Role Objective:

A key objective of this role is to ensure the seamless functioning of Engineering QMS documentation through effective and timely closure of Equipment Preventive Maintenance (PM), Change Controls, Deviations, and CAPA activities in TrackWise. The role is also responsible for managing maintenance schedules, audits, and documentation in compliance with ISO and GMP standards, thereby contributing to the overall reliability, operational efficiency, and cost-effectiveness of the facility.

Desired Candidate Profile:

• Bachelor's degree / Diploma in Mechanical, Electrical, or related Engineering discipline.
• 5–8 years of relevant experience in Engineering & Maintenance within the pharmaceutical, medical device, or manufacturing industry.
• Hands-on experience in QMS documentation, TrackWise, preventive maintenance, and utility management.
• Good understanding of GMP, ISO standards, and audit requirements.
• Strong coordination, documentation, and troubleshooting skills.

Role & Responsibilities:

> Primary Responsibilities:

1. Handle and manage Engineering QMS activities in TrackWise and documentation software.

2. Ensure timely closure of Change Controls, Deviations, CAPA, and Preventive Maintenance records.

3. Maintain preventive maintenance documentation for machining and plant maintenance equipment.

4. Maintain filter cleaning and preventive maintenance records of production equipment.

5. Operate plant machinery and utility systems while ensuring adherence to ISO and GMP standards.

6. Maintain preventive maintenance records, history cards, SOPs, and all relevant engineering documentation.

7. Review daily utility and machine logbooks along with G.E.B. readings.

8. Plan and execute preventive maintenance activities as per approved schedules.

9. Verify and monitor technician and external agency work performance after completion of assigned jobs.

10. Support audit preparation activities and ensure documentation readiness for internal and external audits.

> Secondary Responsibilities:

1. Perform breakdown maintenance of utility equipment including:

• Electrical Motors
• Air Compressors
• Purified Water Plant
• Multi Column Distillation System
• Electrical Panels
• DG Set
• Lighting Systems
• UPS Systems

2. Perform breakdown maintenance of production equipment such as:

• Incubator
• Stability Chamber
• Vacuum Pump
• Filling Machine
• Stirrer
• DHS
• Sterilizer
• Packing Equipment
• Door Closers

3. Ensure timely closure of maintenance work orders with proper documentation.

4. Coordinate with Stores and Utility departments for material procurement and availability.

5. Support auditing activities and engineering documentation management.

6. Participate in facility modification and engineering improvement projects.

7. Manage and submit monthly shift schedules, overtime, and allowance data to the HR department.

8. Ensure the availability and attendance of designated personnel during operational hours.

Functional Skills Required

• Engineering QMS & TrackWise
• Preventive & Breakdown Maintenance
• Utility & Production Equipment Maintenance
• GMP & ISO Documentation
• Audit Preparation & Compliance
• Maintenance Planning & Scheduling
• Root Cause Analysis & CAPA Management

Behavioral Skills Required

• Attention to detail
• Problem-solving ability
• Accountability and ownership
• Team coordination
• Time management
• Communication and documentation skills

Team Size to be Manage:

• Reports to: Senior Manager Engineering & Projects
• Reportee: Individual Contributor role

Important Links:

• Website: https://biotechhealthcare.com/
• LinkedIn: https://www.linkedin.com/company/biotechhealthcare/
• Instagram: Biotech Vision Care

Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.