Sr. Executive - QMS P&E - INJ
Amneal Pharmaceuticals
Ahmedabad, Gujarat, India
Sales / Marketing, Business Development
Key Responsibilities:
Compliance & Documentation
- Ensure all engineering activities are executed in compliance with cGMP, GEP, and site SOPs.
- Ensure compliance with Quality Management Systems (QMS) and applicable regulatory guidelines.
- Handle all quality documents related to engineering such as Change Controls, Deviations, CAPA, and Quality Risk Management.
- Review and update the respective planner and ensure compliance of activity on time.
- Prepare and revise SOPs for plant machinery, utilities, HVAC, and water systems.
- Support preventive maintenance execution as per the defined PM schedule and SOPs.
- Assist engineers in installation and commissioning of new equipment.
- Ensure effectiveness of training through review, feedback, and improvement initiatives.
- Draft and update Job Descriptions for department personnel based on roles and responsibilities.
- Act as the Training Coordinator for the Maintenance Department.
- Update classroom/adhoc training records in training software.
- Generate re-training requirements for SOP changes or compliance gaps.
- Prepare, review, and revise training matrices as per SOP changes or department needs.
- Identify and update training needs (TNI) and ensure compliance with training requirements.
- Manage user creation/inactivation and credential sharing in AIMS software or equivalent systems.
- Ensure new joiners are trained according to function mapping and training plan.
- Upload training materials (new/revised SOP copies) and track completion.
- Attend scheduled trainings and ensure personal and departmental training compliance.
- Prepare and develop engineering layouts, floor plans, equipment layouts, and utility layouts for new and existing projects using AutoCAD and related software.
- Create detailed technical drawings based on specifications provided by the engineering and project teams.
- Collaborate with project engineers, production, and utility teams to gather requirements and translate them into accurate and efficient layouts.
- Maintain proper storage, version control, and backup of all drawings received from vendors and those prepared internally.
- Review and validate vendor-provided drawings for technical accuracy and compliance with project standards.
- Conduct site measurements to verify and update "as-built" layouts post-installation.
- Generate drawing revisions based on feedback and ensure internal approvals are obtained before final release.
- Ensure all systems, documents, and areas are audit-ready at all times.
- Participate in regulatory, customer, and internal audits, and coordinate timely closure of audit observations.
- Maintain compliance trackers and generate regular reports for the HOD and QA.
- Perform additional assignments or responsibilities as assigned by the Head of Department (HOD).
- Contribute to continuous improvement initiatives within the department related to Operation and documentation.
Qualification: B.E (Mechanical / Electrical)
Experience: 4-6 years
About the company
Company website•Pharmaceutical Manufacturing
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
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