2 Fda Regulations Jobs

Head of Engineering & Maintenance- will lead all engineering and maintenance operations for a large-scale API pharmaceutical plant. This role is responsible for ensuring the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. The position requires extensive experience in API manufacturing, including expertise in CGMP, FDA regulations, and managing regulatory audits. Develop and execute maintenance strategies, drive continuous improvement, manage OPEX budgets, and lead a high-performing team to ensure safe, efficient, and compliant plant operations. LOCATION: Digwal, Hyderabad REPORTING STRUCTURE: Reports to Global Engineering & Project head & Site head , Direct reportees all plant engineering & maintenance team ESSENTIAL QUALIFICATION: Bachelors degree in Engineering (Mechanical, Electrical, or related field) RELEVANT EXPERIENCE: > 20 years in a Pharmaceutical API Facility Leadership & Strategy: Lead, manage, and develop the Engineering & Maintenance team to drive plant operational excellence. Develop and execute a comprehensive maintenance strategy, ensuring a proactive approach to maintenance, asset integrity, and equipment reliability. Drive continuous improvement initiatives to optimize plant performance and reduce unplanned downtime. Manage operating expenditure (OPEX) budgets for Engineering & Maintenance activities. Maintenance & Reliability Management : Ensure all critical equipment and systems are maintained in optimal condition to meet production goals and regulatory requirements. Oversee the implementation of preventive and predictive maintenance programs, improving plant uptime and reliability. Develop and implement a comprehensive asset management strategy, including lifecycle management for critical equipment. Regulatory Compliance & Safety : Ensure all maintenance activities are compliant with GMP, FDA, and other relevant pharmaceutical regulations. Promote a culture of safety and adherence to the highest environmental, health, and safety (EHS) standards. Lead the investigation and resolution of any maintenance-related incidents, ensuring timely and effective corrective actions. Team Development & Talent Management : Mentor, train, and develop Engineering & Maintenance personnel, ensuring their skills and capabilities meet the evolving needs of the plant. Foster a culture of collaboration, teamwork, and continuous learning within the team. Lead recruitment efforts to fill skill gaps within the department and drive talent development initiatives. Collaboration & Cross-Functional Coordination : Work closely with Production, Quality, and Supply Chain departments to ensure alignment between maintenance schedules and production plans. Collaborate with the plant leadership team to identify opportunities for process optimization, cost reductions, and productivity improvements. Technology & Innovation : Identify and implement new technologies that improve equipment performance, reduce maintenance costs, and enhance production efficiency. Stay current with industry best practices, technology advancements, and emerging trends in pharmaceutical manufacturing and maintenance Key Competencies: Must have extensive experience in API pharmaceutical manufacturing, with a deep understanding of CGMP, FDA regulations, and other regulatory audit requirements. Expertise in ensuring compliance with these standards while optimizing maintenance strategies and driving operational improvements is essential. The role requires a strong track record in managing audits, addressing non-conformities, and maintaining a high standard of product quality and safety.

Hiring Production Supervisor for a Medical Device Manufacturing company Job Title: Production Supervisor Medical Devices Location: Bengaluru Experience: 5 - 8 Years Department: Manufacturing / Operations Summary of the role: We are seeking a detail-oriented and proactive Production Supervisor to oversee the manufacturing operations of medical devices , with a specific focus on the X-ray tube production line . The role demands strong leadership, technical expertise in high-voltage components, vacuum processing, and precision assembly within cleanroom environments. The ideal candidate will ensure production efficiency, safety, and compliance with ISO 13485 , FDA 21 CFR Part 820 , and Good Manufacturing Practices (GMP) . Key Responsibilities Supervise and coordinate daily activities of production personnel to meet quality and productivity targets. Ensure strict adherence to quality systems ( ISO 13485 ) and regulatory requirements ( FDA 21 CFR Part 820 , GMP). Oversee end-to-end operations of the X-ray tube production line , including oil filling, vacuum sealing, and final encapsulation processes. Monitor production schedules, allocate resources effectively, and ensure timely completion of work orders. Identify, troubleshoot, and resolve production issues, implementing appropriate Corrective and Preventive Actions(CAPA) . Maintain complete and accurate production records, including batch documentation and Device History Records (DHR) . Train, coach, and evaluate production staff on SOPs, safety protocols, and regulatory compliance. Collaborate with cross-functional teams including Quality, Engineering, and Supply Chain to ensure smooth and compliant operations. Support internal and external audits and drive regulatory compliance initiatives. Continuously assess and improve production processes by contributing to Lean manufacturing , 5S , and Kaizen activities. Required Qualifications and Skills Bachelors Degree or Diploma in Engineering(Mechanical, Electrical, Biomedical, or related field). 5+ years of relevant experience in medical device manufacturing , preferably involving high-voltage and vacuum component production. Strong knowledge of ISO 13485 , GMP , FDA 21 CFR Part 820 compliance. Hands-on experience with cleanroom protocols, SOP documentation, and regulated manufacturing environments. Proficiency in handling CAPA, DHR documentation, and batch production reporting. Leadership experience in managing shop-floor teams and cross-functional collaboration. Familiarity with production planning systems and ERP tools is a plus. Key Competencies Leadership & Team Coordination Regulatory Compliance & Documentation Process Troubleshooting & Root Cause Analysis Continuous Improvement Mindset Strong Communication & Interpersonal Skills Attention to Detail and Quality Orientation For further information or any clarification, please reach us on rajbm@mlopssol.com