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Job Description
General Manager - EngineeringJob Description - 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. Essential Qualification Graduate/Post Graduate in Engineering with technical experience.Full time
