*This job is PAUSED right now, but may get open in the future. You may present your information by applying.*
Key Responsibilities :
Reporting to: Manager –Engineering, Project & EHS.
Following responsibilities are applicable for API and Formulation Division.
1. Day to day planning of maintenance related activities and coordination with other departments for any requirement, planning or followup.
2. Conduct cost estimation.
3. To maintain records/ drawings and files according to GMP, Legal & EHS requirements.
4. To provide technical support to external and internal customers.
5. Ensure all relevant safety objectives, requirements are observed for all work completed.
6. To prepare / review Maintenance related SOPs, Schedules, Manuals, Plan, Calibration, Maintenance and validation reports and protocols.
7. Preparations & execution of Preventive Maintenance schedule, Calibration & Validation schedule.
8. To perform Qualification of new and existing euqipments, utility and facility as per Validation Master Policy.
9. To maintain equipments, utilities, safety equipments, site & building as per GMP & EHS requirement.
10. To provide feedback and required information during Management review meetings.
11. To ensure that all records are maintained as per QMS requirement.
12. To follow Data integrity and Quality Policy.
13. To impart training to maintenance and other related personnel on maintenance, work place safety and other subjects as per training need identification.
14. To coordinate with external agencies / legal authorities for inspections / approvals/calibration/ AMC/ maintenance and other requirements.
15. To report deviations to QA department on timely manner with investigation, root cause, CAPA.
16. To ensure CAPA derived from various investigations completed in timely manner.
17. To perform risk assessment of maintenance related activities.
18. To ensure that any change done in accordance to Change control procedure.
19. To take care maintenance related activities.
20. To handover charge related to Project/ Maintenance activity before going on leave to next superior.
21. Ensuring that the Integrated Management system (IMS) conforms to the requirement of ISO 9001:2015 (QMS), ISO 14001:2015 (EMS) and ISO 45001:2018 (OHSAS).
22. Ensure that QMS and IMS processes are delivering their intended outcomes.
23. Report on the operation of the QMS & IMS and identifying any opportunities for improvement.
24. Ensure that IMS policy is promoted, understood and trained throughout the organization.
25. Ensure that the integrity of the system is maintained during changes to the QMS and IMS are planned and implemented.
26. Ensure that responsibilities and authorities relating to the QMS and IMS are communicated and understood.
Job Location : 1 hour from Pune.