Plant Head – EU Approved OSD Manufacturing Facility

Job Title: Plant Head – EU Approved OSD Manufacturing FacilityDepartment: Manufacturing / OperationsLocation: Kala- Amb (Himachal Pradesh)Reports To: Director – Operations / Managing DirectorPosition Level: Senior LeadershipRole Purpose:To lead, manage, and oversee all operations of an EU GMP-approved Oral Solid Dosage (OSD) manufacturing plant, ensuring full regulatory compliance, operational efficiency, and delivery of high-quality pharmaceutical products.The Plant Head will be responsible for strategic planning, production excellence, cost optimization, people development, and maintaining the highest standards of quality, safety, and compliance.Key Responsibilities:1. Leadership & Operations Management· Provide overall leadership to all plant functions including Production, QA, QC, Engineering, EHS, HR, and Supply Chain.· Develop and implement strategic operational plans to achieve production targets, quality standards, and profitability goals.· Ensure effective utilization of resources—manpower, machinery, materials, and utilities.· Drive a culture of accountability, teamwork, and operational excellence.2. Regulatory & Quality Compliance· Ensure strict adherence to EU GMP, MHRA, WHO, and other applicable international and local regulatory guidelines.· Serve as the key site representative during inspections and audits.· Oversee the Quality Management System (QMS) ensuring compliance with all SOPs, documentation, and data integrity norms.· Support Corporate QA and Regulatory Affairs during audits, certifications, and validation activities.· Ensure timely closure of deviations, CAPAs, and change controls.3. Production & Technical Oversight· Manage manufacturing of tablets, capsules, and granules as per approved procedures and specifications.· Ensure smooth technology transfer, scale-up, and process validation for new and existing products.· Monitor and review production KPIs (OEE, yield, downtime, wastage) and drive improvement initiatives.· Implement robust preventive maintenance and calibration systems for all plant equipment.4. People Management & Development· Lead, coach, and develop cross-functional teams for high performance.· Ensure succession planning and skill enhancement for critical roles.· Promote a culture of openness, collaboration, and continuous learning.· Drive employee engagement and ensure compliance with HR and statutory norms.5. EHS & Sustainability· Ensure 100% compliance with Environment, Health & Safety (EHS) policies and statutory requirements.· Conduct regular safety audits, risk assessments, and training programs.· Drive sustainability initiatives, including energy conservation and waste minimization.· Maintain a "zero-accident" and environmentally responsible workplace.6. Continuous Improvement & Innovation· Implement Lean, Six Sigma, and Kaizen practices to improve productivity and reduce costs.· Encourage adoption of digital manufacturing systems (MES, ERP, data monitoring tools).· Collaborate with R&D for process optimization and cost-effective product development.· Benchmark plant performance with industry best practices.Key Interfaces:· Internal: QA/QC, Supply Chain, HR, Finance, Regulatory Affairs, Corporate Management· External: Regulatory Authorities (EU, MHRA, WHO), Auditors, Vendors, and ClientsEducational Qualification:· B.Pharm / M.Pharm / B.E. / M.Tech (Chemical, Mechanical, or Industrial Engineering preferred)Experience:· 18–25 years of experience in pharmaceutical OSD manufacturing, with at least 5 years in a leadership role as Plant Head / Site Head in an EU GMP or MHRA-approved facility.· Proven track record of managing large-scale manufacturing operations, audits, and cross-functional teams.Key Competencies:· Deep understanding of EU GMP and international quality systems.· Strong leadership, communication, and decision-making skills.· Operational excellence and analytical mindset.· Sound knowledge of cost control, budgeting, and performance management.· Commitment to safety, quality, and continuous improvement.Key Performance Indicators (KPIs):· Successful EU GMP / MHRA inspections (no critical observations).· Achievement of production targets and cost efficiency goals.· Quality compliance and reduction in deviations / rejections.· Employee engagement and retention rate.· EHS compliance and incident-free operationPlease feel free to connect @8976869261 and share your CV at shankar.sahu@amnlife.com/hr@amnlife.com