Posted:3 months ago| Platform:
Work from Office
Full Time
Key Responsibility - Must have 2 - 8years experience from Pharma Back ground only. Lead the maintenance and optimization of GMP production and utility machines, including mixers, reactors, filtration systems, dryers, compressors, HVAC systems, pumps, and other critical mechanical equipment. Develop, implement, and manage comprehensive preventive and corrective maintenance plans to minimize downtime and enhance equipment performance in line with GMP guidelines. Troubleshoot and resolve mechanical failures quickly, ensuring minimal disruption to production operations. Perform root cause analysis (RCA) and develop strategies to avoid recurrent issues in compliance with GMP standards. Ensure all required operational and maintenance documentation is maintained and up to date (e.g., daily logs, maintenance schedules, safety audits as per GMP guidelines & Client defined SOPs). Provide weekly, monthly, and quarterly reports on service delivery performance, safety audits, and budgetary status to senior management and the client. Team Leadership and Development: Supervise, mentor, and train mechanical maintenance technicians and engineers to enhance their technical skills and ensure GMP compliance. Organize and delegate maintenance tasks effectively, ensuring that work schedules are met without compromising on quality and safety. Promote a culture of teamwork, continuous improvement, and safety within the maintenance team. GMP Compliance & Regulatory Oversight: 1. Ensure all mechanical maintenance activities are conducted in accordance with GMP standards, ensuring the integrity and safety of the production environment. 2. Perform regular audits and inspections of mechanical systems to ensure compliance with FDA, EMA, and other regulatory bodies. 3. Assist in preparing for regulatory inspections and audits, ensuring that all mechanical systems are in full compliance with industry standards.
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