Senior Executive, Water System at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

16 Jun, 26

Salary

0.0

Posted On

18 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Water System Operation & Maintenance, Equipment Qualification, QMS Compliance, SOP Preparation, Documentation Control, Audit Handling, Regulatory Compliance, Maintenance Planning, Cost Optimization, Team Leadership, Cross-Functional Coordination, Fault Finding, Breakdown Maintenance, Preventive Maintenance, Change Control, Risk Assessments

Industry

Pharmaceutical Manufacturing

Description

Job Role •To prepare draft relevant to QMS element (i.e., CCF, CAPA, Deviation, OOS etc.) and complies it with approval of QA. •To prepare SOP for Operating & maintenance activities related to Maintenance department. •To interact with QMS department for completion of deviation, CCF, CAPA and other activity related to Maintenance department. •Tracking Monitoring of QMS element to compliance in time. •To prepare qualification documents for new equipment/System. •Follow-up with concern to compliance related to QMS element of maintenance. •Coordinate departmental training as per requirement. And cooperate to DTC. •Maintain, organize, and coordinate maintenance documentation in department and Doccell. •Maintain Departmental MOM, Manpower, and external communication documents. •Operating & Maintenance of water system and maintain Daily report. •Fault finding, breakdown and preventive maintenance of water system equipment and systems. •Maintain, review and prepare daily monitoring log sheets of water system equipment and system. •Co-ordination with inter and intra department team for routine activities. •Handling and compliance of QMS elements relevant to Water system. •Maintain the inventory of spares and chemicals relevant to water system. •Lead a team of technicians and junior executives. •Ensure proper maintenance documentation, including logbooks, calibration reports, maintenance records, and SOPs. •Handle regulatory, internal, and customer audits by ensuring documentation readiness and timely closure of audit findings. •Participate in change control, deviation investigations, CAPAs, and risk assessments. •Optimize maintenance costs by improving equipment life and reducing unplanned downtime. Skills: Water System Operation & Maintenance -Proficient Equipment Qualification (IQ, OQ, PQ) -Proficient QMS Compliance (Deviation, CAPA, CCF, OOS) - Expert SOP Preparation & Documentation Control - Proficient Audit Handling & Regulatory Compliance -Expert Maintenance Planning & Cost Optimization -Expert Team Leadership & Cross-Functional Coordination - Expert

Responsibilities

The role involves preparing and managing Quality Management System (QMS) documentation such as SOPs, deviations, and CAPAs, while also overseeing the operation, maintenance, and troubleshooting of water systems. Responsibilities include leading technicians, handling audits, and ensuring compliance across all maintenance activities.