Senior Executive/Junior Manager

3 - 7 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As a member of the Corporate Quality Control department in the Pharmaceutical & Life Sciences industry, your primary responsibility will be to perform the analysis of raw materials, intermediates, and finished products of Active Pharmaceutical Ingredients (APIs). You will operate and maintain analytical instruments like HPLC, GC, UV-Vis Spectrophotometer, FTIR, Karl Fischer, Melting Point Apparatus, among others. Key Responsibilities: - Perform analysis of raw materials, intermediates, and finished products of APIs according to approved specifications and SOPs. - Review and verify analytical data, ensuring proper documentation in compliance with cGMP and GLP guidelines. - Prepare and standardize volumetric solutions and reagents, conduct stability studies following ICH guidelines, and ensure timely calibration of laboratory instruments. - Participate in method validation/transfer activities as per regulatory requirements and investigations related to OOS, OOT, Deviations, and CAPA implementation. - Collaborate with QA, Production, and R&D departments to ensure a smooth workflow. Qualifications Required: - Hands-on experience in analytical techniques, especially with HPLC and GC instruments. - Solid understanding of regulatory guidelines such as ICH, WHO, and USFDA. - Strong documentation and communication skills. - Prior experience in a regulated API manufacturing unit. (Note: No additional details of the company are provided in the job description),

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