Sr. Executive - QMS P&E - INJ

Amneal Pharmaceuticals


Date: 3 weeks ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description

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.

Department Training Coordinator 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.

Layout Preparation And Drawing Management

  • 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.

Audit Readiness & Support

  • 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.

Other Duties

  • 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.

Qualifications

Qualification: B.E (Mechanical / Electrical)

Experience: 4-6 years

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Engineering Technician

Ingersoll Rand, Ahmedabad, Gujarat
3 hours ago
Ingersoll Rand is committed to achieving workforce diversity reflective of our communities. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion,...

Process Assistant

Amazon, Ahmedabad, Gujarat
1 day ago
DescriptionAt Amazon, we strive to be Earth’s most customer-centric company where people can find and discover anything they want to buy online. We hire the world’s brightest minds, offering them an environment in which they can relentlessly improve the experience for customers. Innovation and creativity are built into the DNA of the company and are encouraged at all levels of...

Executive, IPQA EM

Amneal Pharmaceuticals, Ahmedabad, Gujarat
2 days ago
Key Responsibilities JOB DESCRIPTION Environment monitoringAseptic area behaviour and monitoringHandling of Instrument i.e NVPC and MAS.Personnel monitoringTrend analysis and reportingSample handlingQualificationsQualification: M.Sc (Microbiology) / B.PharmExperience: 3-4 yearsEM monitoring in aseptic process area including Grade A,B,C and D