20 - 24 years

0 Lacs

Posted:23 hours ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As the Head of Manufacturing API, you will be responsible for overseeing all API production activities at our Atchutapuram, Andhra Pradesh facility. With over 20 years of experience in API manufacturing, you will lead the team to ensure safe, compliant, and efficient manufacturing operations. Your role will involve achieving production targets, maintaining cGMP compliance, and driving continuous improvement across the API manufacturing units. Your key responsibilities will include: Production Management: - Planning and executing API manufacturing based on production schedules. - Ensuring adherence to batch production records (BMRs) and standard operating procedures (SOPs). - Optimizing process yields and reducing production cycle time. - Reviewing and approving production documentation. Compliance & Quality Assurance: - Ensuring full compliance with cGMP, ICH, and regulatory requirements. - Coordinating with QA/QC for timely release and in-process quality checks. - Supporting regulatory inspections and customer audits. - Implementing corrective and preventive actions (CAPAs) and change controls. Team Leadership & Development: - Leading and managing a team of production managers, supervisors, and operators. - Providing training and performance management to manufacturing staff. - Fostering a culture of safety, quality, and operational excellence. Safety & Environment: - Enforcing EHS policies and ensuring zero accidents. - Leading risk assessments and incident investigations. - Monitoring effluent treatment and hazardous waste management. Process Improvement & Technology Transfer: - Collaborating with R&D and Tech Transfer for smooth scale-up and validation. - Supporting new product introductions (NPI) and technology transfers. Budget & Cost Control: - Managing manufacturing budgets, OEE, and resource planning. - Monitoring raw material and solvent usage for cost optimization. - Working with procurement to ensure timely availability of materials. In this role, your leadership, technical expertise, and strategic thinking will be crucial in driving the success of our API manufacturing operations.,

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