Role Overview :
Royal Pharma is looking for an experienced and dynamic Site Head to lead the operations of our new API / Advanced Intermediates manufacturing facility. The ideal candidate will be responsible for overseeing production, quality, regulatory compliance, safety, and operational efficiency to ensure seamless plant operations while maintaining cost-effectiveness and adherence to regulatory guidelines.
Key Responsibilities :
1. Plant Operations & Production Management
- Oversee end-to-end plant operations, ensuring smooth production of APIs and advanced intermediates .
- Drive process efficiency, production planning, and optimization to meet business targets.
- Implement best practices for yield improvement, cost reduction, and waste minimization.
2. Compliance & Regulatory Affairs
Ensure adherence to cGMP, FDA, EHS, USFDA ,EDQM and other global regulatory requirements .Oversee internal and external audits, regulatory inspections, and compliance documentation.Collaborate with quality teams to maintain high QA / QC standards .3. Safety, Health, and Environment (SHE)
Establish and enforce SHE policies to maintain a safe work environment.Drive sustainability initiatives and strong effluent management practices.4. Team Leadership & Development
Build and lead a high-performing technical and operations team.Implement training programs to enhance workforce competency and operational excellence.5. Cost Management & Budgeting
Optimize operational costs while ensuring high product quality and plant efficiency.Manage budgets for manpower, raw materials, utilities, and capital expenditure.6. Collaboration & Stakeholder Management
Work closely with R&D, Supply Chain, Quality, and Regulatory teams for new product scale-up and commercialization.Maintain strong relationships with key stakeholders, including regulatory bodies, suppliers, and customers .Key Skills & Competencies :
Experience in Heading site functions.Experience in process optimization, cost control, and operational excellence.Deep understanding of GMP, regulatory guidelines (USFDA, EMA, WHO), and EHS policies .Excellent problem-solving, decision-making, and people management skills.Location : Boisar : Tarapur – Mumbai / Maharashtra
Industry : Must be (API / Advanced Intermediates - Pharmaceutical Manufacturing Plant)
Employment Type
Full-time
Skills Required
Fda, Cgmp, Ehs, Qa, Usfda, Qc, Api