Senior Manager - Maintenance For Reputed API / CDMO company

Role & responsibilities

1)Supervise compliance to all cGMP or any other regulatory requirements, including EH&S

(2)Implement and ensure all tasks and activities as per the applicable SOPs and cGMP/GEP.

(3)Planning of scheduling of preventive and periodic maintenance, effective handling of breakdown in the plant, utilities & ETP equipments with minimum possible down time. Operation & maintenance of utility & water system.

(4)Utility operation & maintenance, MIS preparation

(5)Engineering project planning to commissioning

(6)Budget preparation, maintain inventory control of engineering items & cost control and vendor development.

(7)Maintain online maintenance related documents as per regulatory requirements and audit compliance.

(8)Prepare CAPEX, coordinate for budget approval, CER approval process with stakeholder on project related work, co-ordination with purchase and user department

(9)Finalization of specification sheet, vendor approval, procurements as per URS, ensure FAT and SAT etc.

(10)Finalization of ARC / AMC vendor by techno-commercial evaluation and vendor agreement process.

(11)Ensure the training is imparted to employees and contractual workmen for the respective ISO process, execute a role of implementation of ISO related activities.

(12)Exposure to SAP PM module preferred.