Maintenance Engineer I

How You’ll Spend Your Day

1. Quality Management System (QMS) :

1. 1. Continuous assessment of QMS to mitigate quality risks and strengthening quality culture.
   2. To ensure adherence to global quality, corporate, and regulatory standards during all compliance‑related activities
   3. Prepare, review, and update Engineering Standard Operating Procedures (SOPs) to identify and close gaps related to regulatory, corporate, and quality requirements.
   4. Manage the timely initiation, review, and closure of QMS documentation, including CAPA, Change Controls(CC), Deviations, Risk Assessments(RA), and Impact Assessments(IA).
   5. Perform periodic verification and review of Engineering‑related GxP documentation to assess completeness and compliance with Data Integrity (DI) principles.
   6.  To Provide backup support for the Engineering during Cross‑Functional Team (CFT) meetings, timely execution of QMS‑related activities and assigned tasks.
   7. To ensure All‑Time Readiness (ATR) for regulatory inspections by coordinating required documentation, supporting audit preparation activities, and maintaining effective communication with CFTs to ensure timely compliance.
   8. To provide backup support for all GMP manufacturing & GxP activity ensuring all equipment complies with comply with approved SOPs, policies, and regulatory requirements.
   9. To prepare , review and manage documentation related Risk Assessment related document of Engineering department.
   10. To ensure that the Engineering Quality Management System remains in a continuous state of compliance.
   11. To support the identification , introduction of alternate vendors .
   12. To handle and support Change control, Deviation & CAPA, investigation as per defined standard procedure.

1. Calibration, Qualification and Training:

1. 1. Management of calibration planning and timely execution as per calibration scheduler.
   2. To explore for re-categorization of calibration instruments to save cost and time.
   3. Management of equipment‘s.qualification planning and timely execution of activity against schedule as per planner.
   4. Review of protocol and associated reports to ensure its compliance as per regulatory and site norms.
   5. To ensure timely allocation of required training to identified personnel and completion of training activities within due date.
   6. To mointor , access and track training assessment and tracking of training activity and schedular.
   7. To Prepare and Support for instrument related CAT,RA and IA.
   8. To Interact with STC and global for recent updation in training system.
   9. To review HVAC Qualification and Validation.

3. Safety Management

1. 1. Management of safety Audits and timely closure of observaion.
   2. To roll out and ensure implementation of best safety rules, procedures and practices.
   3. To ensure that notification, investigation, and case management of injuries related to engineering activity and incidents are in collaboration with management.
   4. Any other job activity as assigned by the reporting Manager/ Management from time to time.

4. Documentation Support

1. 1. To draft, handle and archival of document related to GAP identified during remediation and timely closure of task after remediation completion.
   2. To handle documentation related to New Project.
   3. To Review and Approval of Protocols.