Amneal Pharmaceuticals
Website:
amneal.com
Job details:
Job 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
Qualifications
Educational Qualification: B.Tech / B.E / M.Tech
Experience: 7-10 Years.
Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role.
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