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7.0 - 15.0 years
0 Lacs
chennai, tamil nadu
On-site
You should have over 15 years of experience in Warehouse operations, including at least 7 years in a supervisory role within injectable manufacturing. Your role will require a strong understanding of regulatory requirements, cGMP, and industry best practices. You should possess proven leadership abilities and excellent communication skills to effectively work cross-functionally and resolve quality-related challenges efficiently. Previous experience in successfully facing regulatory audits, including USFDA, EU-GMP, and ANVISA is mandatory. In terms of Material Receipt and Storage, you will be responsible for ensuring that all materials are stored and handled in compliance with cGMP and regulatory requirements. Regular recording of temperature, RH, and DP in designated logbooks is essential to maintain optimal storage conditions. Warehouse Maintenance and Cleanliness will also fall under your purview. You must ensure the cleanliness and organization of the warehouse at all times. Your duties will also involve Material Handling and Dispensing, where you will be required to dispense raw materials and issue packing materials following the FIFO (First In, First Out) system. Proper handling, storage, and distribution of materials in alignment with company procedures and safety standards are vital. Compliance and Documentation are key aspects of the role. You will need to ensure compliance with cGMP standards and regulatory requirements in all warehouse operations. Maintaining up-to-date inward registers, following good documentation practices (GDP), and participating in audits and compliance assessments are crucial responsibilities. Safety and Hygiene protocols must be strictly adhered to. This includes ensuring that safety protocols and hygiene standards, including personal hygiene and gowning procedures as per SOPs, are followed by the warehouse team during work operations. Quality Risk Management is another critical area where you will be involved. Handling rejected materials, coordinating their disposition, participating in Quality Management System (QMS) activities, and conducting regular quality risk assessments are all part of maintaining quality standards in warehouse processes. Your role will require you to ensure that warehouse processes, documentation, and operations are audit-ready at all times.,
Posted 2 days ago
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