Employer description & source details
We are looking for an individual to ensure strict adherence to safety protocols, SOPs, and quality standards, ensuring batch manufacturing activities, coordinating with various departments to maintain operational efficiency. The role involves executing production activities, coordinating with cross-functional teams and meeting production targets. You will be responsible for adherence to company safety norms, policies, and SOPs (Standard Operating Procedures). You will execute batch manufacturing activities according to e-BMR instructions and workflow, ensuring submission of executed e-BMR and workflows to IPQA (In-Process Quality Assurance) department. With support of the MSAT and IPDO team execute trial, validation and commercial batches. You will be accountable for timely completion of calibration, preventive maintenance activities, and reducing production breakdown time through coordination with shift in-charge and engineering department You will initiate quality notification, breakdown notification You will involve in commissioning and qualification activities of the equipment You will ensure qualification, validation, calibration of equipment, and process validation are done as per schedule and requirements. You will ensure clean room practices are followed as per the SOP and maintain as per the desired conditions You will be responsible for maintaining overall operating area to meet current regulatory compliance and norms Proficiency in utilizing MES software to execute batch manufacturing activities and ensure compliance with e-BMR instructions. Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to ensure compliance with regulatory requirements and quality standards. Experience in executing the qualification, validation, and ca
Extracted skills: operations