General Manager - Engineering

Piramal Pharma Solutions

0 years

0 - 6 Lacs

dhār

Posted:2 days ago| Platform: GlassDoor logo

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Skills Required

engineering maintenance compliance documentation support data integrity monitoring reports collaboration sap optimization erp modification management audits schedule analysis planning training development controls

Work Mode

On-site

Job Type

Part Time

Job 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.

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