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0.0 years

0 Lacs

chennai, tamil nadu, india

On-site

Role Summary Responsible for reviewing documents related to product development, analytical data (including electronic data, chromatographic data, and audit trails), as well as instrument and equipment qualification Accountable for ensuring data integrity compliance and adherence to SOPs during the review of both hard copy and electronic records Conduct periodic system audit trail reviews and ensure compliance with 21 CFR Part 11 requirements Liaise effectively with global BL and OQ colleagues to achieve organizational objectives Maintain a thorough understanding of ICH quality guidelines and relevant regulatory guidance on microbiology method development pertaining to sterility, BET, CCIT, ...

Posted 1 week ago

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