Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.
Post : Manager 2 - Formulation Development Non Orals
Job Description
• Review documents required for regulatory submissions across global markets, including product development reports and scientific justifications for responding to regulatory queries.
• Evaluate and review documents related to technology transfer to ensure accuracy and regulatory compliance.
• Review protocols and reports for various product development studies of Non-Oral products to ensure scientific soundness and regulatory alignment.
• Review documents required for drug-device combination products in accordance with applicable regulatory requirements.
• Review filter validation reports and conduct risk assessments for extractables and leachables, elemental impurities, and nitrosamine impurities.
• Prepare and review Standard Operating Procedures (SOPs) and internal guidelines to ensure system compliance.
• Review investigation reports related to failures, Out of Specification (OOS), and Out of Trend (OOT) results, and support root cause analysis.
• Ensure adherence to internal quality systems and regulatory standards & conduct SOP training.
Additional Information
Tenure : 9-11 years
Qualification : M.Pharm
Location : Baroda
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Formulation Development Non Orals
End Date : 30th September 2025
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