Senior Executive 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. 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.
Work Experience 8 to 10 years Education Diploma in Electrical or Instrumentation B.Tech in Electrical or Instrumentation Competencies 2. Innovation & Creativity 3.
Customer
Centricity 5.
Result Orientation Key Note
Click 'Save' on the right to avoid losing your entered data. After saving, go to the top of the page and click on the Job Requisition Details tab (next to Job Profile) to proceed.