Company: Sun Pharma - R&D Baroda
Post: Sr. Exe / Manager - DQA - Biosimilar
Experience: 6 to 9 years
Job Description:
- Exposure to product development, analytical development, CMC, regulatory filing, RCGM and CDSCO requirements for recombinant products. Exposure to filing in regulated markets (EMA/FDA/PMDA/TGA/HC/ANVISA) would be preferred.
- Should have a good understanding of regulatory guidelines (RCGM, CDSCO, ICH & ISPE)
- Officiate in Quality Assurance functions of early-stage development of biologics, biosimilar and vaccines
- Responsible for lifecycle management of developing products with respect to knowledge management and lifecycle management as per ICH. Management of process changes in early phase development
- Review of clone development and cell banking documentation and ensuring regulatory compliance in plans and reports
- Review of product development documents such as process development reports, process descriptions, process control strategy documents etc.
- Review of analytical developments such as method development reports, method qualification/validation protocols and reports and ensure compliance.
Send in your resume to: rosemary.varghese@sunpharma.com
Freshers need not apply.
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