Plant Head - Pharmaceuticals (API Manufacturing)

Location: Visakhapatnam

We seek a dynamic Plant Head to spearhead manufacturing operations and ensure regulatory compliance at Synnat Pharma. As Plant Head, you will be responsible for overseeing all aspects of pharmaceutical manufacturing, from production planning and execution to quality assurance and regulatory adherence. Your leadership will be crucial in driving continuous improvement initiatives, managing risk, and ensuring the highest standards of product quality and safety.

Responsibilities

Manufacturing Operations Leadership

• Oversee all manufacturing operations within the pharmaceutical facility, ensuring efficient and compliant production processes.
• Provide strategic leadership and direction to the manufacturing team, fostering a culture of continuous improvement and operational excellence.
• Develop and implement manufacturing strategies to optimize production output, reduce costs, and enhance product quality.
• Ensure compliance with all applicable GMP regulations and company policies, maintaining a state of audit readiness.
• Manage and mentor a team of manufacturing professionals, providing guidance, training, and performance feedback.
• Drive initiatives to improve manufacturing efficiency, reduce waste, and enhance overall operational performance.

GMP and Regulatory Compliance

• Ensure strict adherence to Good Manufacturing Practices (GMP) across all manufacturing operations.
• Manage and oversee regulatory audits, ensuring successful outcomes and timely resolution of any findings.
• Develop and maintain comprehensive documentation related to GMP compliance, including SOPs, batch records, and validation protocols.
• Stay abreast of evolving regulatory requirements and implement necessary changes to ensure ongoing compliance.
• Lead the development and execution of validation plans for manufacturing processes and equipment.
• Oversee the management of deviations, investigations, and corrective actions, ensuring timely and effective resolution.

Quality Assurance and Control

• Collaborate with the Quality Assurance (QA) team to establish and maintain robust quality control systems.
• Ensure that all products meet established quality standards and specifications.
• Oversee the implementation of quality control procedures and monitoring programs.
• Manage the investigation of quality issues and implement corrective and preventive actions (CAPA).
• Review and approve quality control documentation, including test results and certificates of analysis.
• Participate in quality audits and inspections, both internal and external.

Production Planning and Execution

• Develop and implement production plans to meet customer demand and inventory targets.
• Coordinate with supply chain and procurement to ensure timely availability of raw materials and components.
• Monitor production performance and identify areas for improvement.
• Manage production schedules and optimize resource allocation.
• Ensure accurate and timely reporting of production data.
• Troubleshoot production issues and implement corrective actions.

Facilities and Utilities Management

• Oversee the maintenance and operation of the pharmaceutical manufacturing facility.
• Ensure the reliable and efficient operation of utilities, including water, electricity, and HVAC systems.
• Manage facility maintenance schedules and ensure timely completion of repairs and upgrades.
• Implement and maintain a robust preventive maintenance program.
• Ensure compliance with environmental regulations and safety standards.
• Manage facility budgets and control costs.

Risk Management and Project Management

• Identify and assess potential risks to manufacturing operations.
• Develop and implement risk mitigation strategies.
• Manage pharmaceutical projects, ensuring timely completion and adherence to budget.
• Coordinate with cross-functional teams to ensure project success.
• Track project progress and report on key milestones.
• Implement change control procedures to manage modifications to manufacturing processes and equipment.