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Executive/Sr. Executive-Manufacturing QMS

1 - 8 years

0 Lacs

ahmedabad gujarat

Posted:5 days ago| Platform: Shine logo

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Skills Required

qms upstream downstream audit compliance regulatory guidelines sop bmr preparation manufacturing process operations bacterial products recombinant vaccine biological therapeutics

Work Mode

On-site

Job Type

Full Time

Job Description

You will be responsible for managing the Quality Management System (QMS) for drug substance of bacterial products. It is essential to have a solid understanding of the process involved in both upstream and downstream unit operations. Your role will involve handling QMS documents including deviations, change controls, and investigations using Track-wise software. In addition, you should have experience in ensuring audit compliance, adherence to regulatory guidelines, and proficiency in documentation such as Standard Operating Procedures (SOPs) and Batch Manufacturing Record (BMR) preparation. This position requires a minimum of 5-8 years of experience in QMS, compliance, and documentation, with a strong understanding of manufacturing process operations related to bacterial and recombinant vaccines, as well as biological therapeutics.,

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