Responsible for routine, preventive and breakdown maintenance of following areas :

1. API manufacturing block

2. API warehouse

3. Quality control & microbiology laboratory

4. Central utility

5. Electrical substation

6. Onsite & offsite ETP

7. Solvent tank form area

8. Site Infrastructure

9. Instrumentation

10. Admin Block

Job Description :

- Responsible for adherence to GMP/USFDA norms for various projects and maintenance. Awareness with fabrication drawings, capable to ensure the documentations related to GMP, URS, DQ, IQ, OQ, PQ etc. Interfacing with the approving authorities and coordinating with consultants.

- Ensure the business unit facility equipment, premises, utility systems are well maintained as per cGMP & GEP.

- Responsible for major/minor facility modifications and major maintenance activities within the business unit.

- Ensure compliance related to QMS, EHSS management system

- Managing major modification and maintenance activities related to functional areas and equipment including planning, execution, calibration, qualification and validation in coordination with user.

- Meet regulatory & statutory requirements related to functional areas

- Ensure all the audit findings are closed within the stipulated time

- Statutory responsibility that include getting certified elevators, pressure vessels, boilers, electrical equipment, building stability, lifts and stackers

- Monitoring and controlling consumption of utilities like electrical power, water etc., conducting periodic self-inspection and third-party audits as appropriate.

- Train and develop team to perform regular maintenance activities

- CapEx&OpEx - Costing and budgeting of respective functional area

- Assign objectives for the team members

- Training on SOP's for the team members

- Implementation of cGMP, GEP, SOP as applicable

Requirements :

- Degree in Civil/Mechanical/Electrical or related Engineering discipline, Master's degree would be preferable

- Minimum of 20 years of experience; experience of having led mid-large-scale projects in pharma/life sciences research industry is desirable

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