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