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Executive/Senior Executive-Analytical Documentation

2 - 4 years

0 - 1 Lacs

Hyderabad

Posted:6 days ago| Platform: Naukri logo

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Skills Required

SOP STP preparation LNB Specifications Analytical Documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are seeking a dynamic and detail-oriented Analytical Documentation professional with 2-4 Years of experience to join our growing team. This role is critical to ensuring quality and compliance during the pharmaceutical product development lifecycle. Key Responsibilities 1. To Follow the Departmental SOPs. 2. Preparation of Raw materials, In-process and Finished product specifications and standard test procedures. 3. To review/revise/obsolete the Raw materials, In-process and Finished product specifications and standard test procedures as per requirements. 4. Handling of pharmacopeial updations. 5. Preparation of Regulatory assessment documents required for filing Viz., Elemental impurities assessment, Nitrosamine impurities assessment, Residual solvents risk assessment reports. 6. Handling of Quality notifications like CCNs, Incidents, Events etc., 7. Preparation or revision of Departmental SOP’s and GTPs. 8. Receiving logbooks, SOPs or any issued documents from QA. 9. Ensuring the compliance with respect to good documentation practice and good laboratory practice. 10. To ensure the error free and online documentation. 11. To ensure the archival of completed documents and files. 12. Complete trainings in Eduzen and document control in Docuzen and close the CAPA in Qualzen. Interested candidates can share their resumes to raghuveera.vutla@aizant.com Note: Immediate Joiners are more preferable

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Information Technology and Services

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    Key People

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  • Rekha M. Choudhury

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