Sun Pharma – Urgent Opening for Quality Assurance- R & D Apply Now

Sun Pharma – Urgent Opening for Quality Assurance- R & D Apply Now

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 4.5 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.

Hirng 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 .

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