Job Description

Hiring Alert !
Function – R&D Formulation Development – Non Orals (DQA) Vadodara
Experience : M.Pharm with 8-10 years in DQA

Job Description
1) Review documents required for regulatory submissions across global markets, including product development reports and scientific justifications for responding to regulatory queries.
2) Evaluate and review documents related to technology transfer to ensure accuracy and regulatory compliance.
3) Review protocols and reports for various product development studies of Non-Oral products to ensure scientific soundness and regulatory alignment.
4) Review documents required for drug-device combination products in accordance with applicable regulatory requirements.
5) Review filter validation reports and conduct risk assessments for extractables and leachable, elemental impurities, and nitrosamine impurities.
6) Prepare and review Standard Operating Procedures (SOPs) and internal guidelines to ensure system compliance.
7) Review investigation reports related to failures, Out of Specification (OOS), and Out of Trend (OOT) results, and support root cause analysis.
8) Ensure adherence to internal quality systems and regulatory standards & conduct SOP training.

Send us your resume to : Rosemary.varghese@sunpharma.com