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Plant Head – EU Approved OSD Manufacturing Facility

Plant Head – EU Approved OSD Manufacturing Facility

AMN Life Science Pvt. Ltd.Amravati, IN
18 hours ago
Job description

Job Title : Plant Head – EU Approved OSD Manufacturing Facility

Department : Manufacturing / Operations

Location : Kala- Amb (Himachal Pradesh)

Reports To : Director – Operations / Managing Director

Position Level : Senior Leadership

Role 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 Clients
  • Educational 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 operation
  • Please feel free to connect @8976869261 and share your CV at shankar.sahu@amnlife.com / hr@amnlife.com

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