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General Manager - Engineering
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- Ensure efficient operation, maintenance and upkeep of Plant Equipment and Utilities.
- Maintain, improve and keep updated all Engineering Documents and records
- Ensure compliance to Quality, Safety and Regulatory requirements.
- Ensure compliance of SOPs, cGMP practices along with good documentation and record keeping.
- Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.
- Ensure timely execution of preventive and breakdown maintenance as per SOP..
- Maximizing plant uptime by keeping track of OEE & breakdown reports.
- Meet internal customer expectations on costs and quality deliverables
- Foster a disciplined, inclusive, and transparent work environment promoting fairness and collaboration.
- Control engineering costs within approved and sanctioned budget limits.
- Ensure uninterrupted utility services to plant to achieve targeted production.
- Identify energy conservation opportunities and lead energy-saving projects and initiatives.
- Approve engineering purchase requisitions in the SAP system.
- Review and approve engineering challans and vendor bills.
- Ensure execution and timely completion of various projects.
- Monitor & control the Engineering CAPEX and OPEX budget.
- Lead cost optimization and de-bottlenecking initiatives.
- Actively participate in ERP implementation, refurbishments, and facility modification projects.
- Periodically review and update departmental SOPs.
- Stay updated with regulatory guidelines (USFDA, MHRA, MCC, MCA, etc.) and train team members on new requirements.
- Participate in bilateral discussions, including wage settlements and labor-related matters.
- Perform duties of the Management Representative (MR) for the EHS Management System.
- Ensure effective implementation of EHS systems as per ISO 14001:2015 and ISO 45001:2018 standards.
- Actively participate in ISO 14001, ISO 45001, ISO 13485 audits, and Management Review Meetings.
- Ensure compliance with regulatory requirements from agencies such as USFDA, EU, TGA, MHRA, ANVISA, WHO, and Schedule M.
- Participate in validation activities as per the protocol.
- Review of various RFPs (Request for Proposal) from customer and preparing Gap analysis.
- Lead budget preparation and manpower planning, including CAPEX and OPEX finalization.
- Prepare capital investment proposals for new products and facility modifications..
- Ensure knowledge and involvement in SFTI and conduct periodic reviews of AET team performance.
- Counsel employees on discipline, productivity, quality, and system deviations; issue advisory/warning letters through HOD and HR.
- Set KRA for reportees and monitor the progress. Give periodic feedback regarding performance and guide whenever necessary.
- Support the Accounts team in preparing cost sheets for new and potential business projects.
- Identify training needs and coordinate with HR for execution of development programs.
- Review and approve Change Controls, Deviations, and CAPAs in the electronic quality management system.
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