Assistant Production Manager

We are looking for a meticulous Asst. Manager Production to lead production activities at Synnat Pharma Private Limited, ensuring seamless API manufacturing operations and adherence to the highest quality standards. As Asst. Manager Production, you will play a pivotal role in overseeing daily production activities, monitoring validation batches, and ensuring compliance with cGMP guidelines. Your responsibilities will include the preparation and review of production-related documents, coordination with cross-functional teams, and active participation in internal and external audits. You will also be responsible for identifying and resolving operational gaps, managing deviations and Out-of-Specification (OOS) incidents, and implementing Corrective and Preventive Actions (CAPA). With a strong focus on process optimization and continuous improvement, you will contribute to enhancing production efficiency and maintaining a facility that is always audit-ready. Your expertise in QMS (Quality Management Systems) and experience with ERP systems (SAP) will be crucial in driving operational excellence and ensuring the delivery of high-quality pharmaceutical products.

Responsibilities:

• Oversee daily API production activities, ensuring compliance with established procedures and cGMP guidelines.
• Monitor validation batches, process parameters, and Batch Manufacturing Records (BMR/MBMR) for accuracy.
• Verify online BMRs and ensure compliance with regulatory and documentation standards.
• Coordinate with utility, QC, Stores, and Engineering teams to support seamless production operations.
• Supervise movement of finished products, intermediates, and recover solvents as per protocols.
• Identify and resolve operational gaps at the floor level to improve efficiency.
• Manage deviations, Out-of-Specification (OOS) incidents, and implement CAPA measures effectively.
• Ensure compliance with QMS and audit requirements; participate in internal and external audits.
• Prepare, review, and maintain accurate production documents, including validation protocols and training records.
• Develop preventive maintenance schedules, monthly production plans, and calculate raw material requirements.
• Train and mentor team members on production processes, compliance, and quality standards.
• Report production activities, deviations, and audit compliance to management while driving process improvements.

General Expectations and Past Experiences:

• Strong understanding of API Manufacturing processes and cGMP guidelines.
• Demonstrated experience in preparing and reviewing production-related documents, including BMRs, validation protocols, and SOPs.
• Proven ability to manage and resolve deviations and Out-of-Specification (OOS) incidents effectively.
• Proficiency in using ERP Systems (SAP) for production planning, inventory management, and data analysis.
• Experience in participating in and contributing to successful internal and external audits.
• Strong leadership and communication skills with the ability to train and mentor production staff.
• In-depth knowledge of Cleaning Validation procedures and QMS (Quality Management Systems).