Sr Compendial Review Associate

6 - 10 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Job Description: As a member of the team, you will be responsible for identifying, reviewing, and implementing Pharmacopeial updates on a global scale. This will involve conducting activities related to the revision of product specifications and methods through a change management process. You will also be required to assess the impact of changes and review updates to ISO Guidelines. Additionally, you will collaborate with various departments to ensure compliance with USP/NF or other Pharmacopeial standards and ISO Guidelines. Regular reporting of work completion status to the reporting manager and coordination with them for updates to the management will be essential tasks. You will also be involved in preparing quality metrics, conducting risk assessments related to the Compendial Review Team, and ensuring compliance with the QMS system. Furthermore, your role will include the preparation, review, and implementation of common SOPs, procedures, and policies. Your educational background should include an M.Pharmacy/M.Sc degree, along with a minimum of 6 to 8 years of experience in QC/QC reviewer/QA (GMP). This position requires strong attention to detail, excellent communication skills, and the ability to work effectively in a dynamic and regulated environment. If you are passionate about ensuring quality and compliance in pharmaceutical processes, this role will provide you with the opportunity to make a significant impact in the industry.,

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