11 Sep
|
Biotech Healthcare
|
Ahmedabad
11 Sep
Biotech Healthcare
Ahmedabad
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.
- Solid 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.
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📌 Senior Executive QMS Maintenance (Ahmedabad)
🏢 Biotech Healthcare
📍 Ahmedabad