Hiring alerts: Sun Pharma – R&D Baroda
Sr. Exe / Manager – DQA – Biosimilar
Experience : 6 to 9 years
Brief JD:
1) Exposure of product development, analytical development, CMC, regulatory filing, RCGM and CDSCO requirements for recombinant products. Exposure of filing in regulated markets (EMA/FDA/PMDA/TGA/HC/ANVISA) would be preferred.
2) Should have good understanding of regulatory guidelines (RCGM, CDSCO, ICH & ISPE)
3) Officiate in Quality Assurance functions of early stage development of biologics, biosimilar and vaccines
Responsible for lifecycle management of development products with respect to knowledge management and lifecycle management as per ICH. Management of process changes in early phase development
4) Review of clone development and cell banking documentation and ensuring regulatory compliance in plans and reports
5) Review of product development documents such as process development reports, process descriptions, process control strategy documents etc.
6) Review of analytical developments such as method development reports, method qualification/validation protocols and reports and ensure compliance .
Send in your resume to : [email protected]
Fresher’s need not apply.
