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
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.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
