Engineering (Inject) | Sr. Executive I Nagpur Injectable plant USFDA

7 days ago

Nagpur, India Select Source International Full time

Experience: 11 to 15 years

Education: BE

Designation: Sr. Executive- E3

Budget: Upto 15 LPA Nego

Key Role: Process & Water System Lead:

Job Description:

  • Hands on experience on injectable process equipment like Vial filling lines, PFS filling lines, Isolators, Lyophilizers, and Steam Sterilizers maintenance and ability to lead team of 5-10 members.
  • Candidate should have good exposure to Water Systems.
  • Implementation and review of departmental documentation, validation & QMS activities. Shall have Hands-on experience on Change Control Management, Investigations & CAPA modules. Tracking allocated QMS task completion and closer within time.
  • Analysis of breakdown notifications.
  • Planning and execution of SAP preventive maintenance and timely closure.
  • Maintaining and procurement of critical spare parts. Should be innovative, self-starter and work within the allocated budget. Focus on reverse engineering.
  • Develop and coordinate with external vendors for and developing of indigenous spare parts and maintenance activities.
  • Lead continuous improvement initiatives in the filling lines to increase process efficiency, energy conservation and capacity while maintaining a high level of quality.
  • Ensure compliance to cGMP and quality system.
  • Having exposure to face the regulatory auditors like USFDA, MHRA, ANVISA and TGA etc.
  • Prepare the budget and capex for the engineering department and monitoring of yearly expenditure of engineering department.
  • Ensuring compliance of safety policies, safe work environment for all the team members, external party, contractors etc.
  • Legal compliance with respect to safety & environment, licensing with government authorities.

If interested Mail cv at :-

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