CMC QA API Group Team member | Sun Pharma | Gurgaon

Job Description

Roles and Responsibilities:

• To provide support to the group to ensure the achievement of CMC Quality accountabilities and responsibilities of Baroda R&D. 
• To be accountable for developing procedures/systems and for assuring compliance to them by the R&D function. 
• To ensure the Compliant Development of Chemical Entities, Key starting Materials, Intermediates, API, and their technology transfers to the manufacturing organization. 
• Review and audit R&D procedures, specifications, stability data, reports and SLP/Process packages, and other technology transfer documents of drug substance / Intermediates development for completeness & adequacy, and justification prior to transfer to manufacturing sites 
• To assure that process development packages up to the filling stage of R & D deliverables are reviewed adequately within the team to verify scientific rigor, adequacy, and completeness. 
• To implement and monitor enabling processes/practices, such as the R&D stage gate process, development standards, and acceptance criteria. 
• To ensure the Compliant Development of Analytical Methods, Method Qualification, and Method Validation activities related to Chemical Entities, API, and their method transfers to the manufacturer organization. 
• Review of Harmonization Sops, Guidelines, and implementation 
• Review of facility and equipment qualification and calibration records 
• Support and participate in failure investigations and resolution of root causes for issues related to systems and products developed within Sun Pharmaceutical Industries Limited 
• Reviewing deviation/Change controls / CAPA and associated investigation reports prior to Technology Transfer 
• Knowledge on evaluation of Nitrosamine impurities in drug substances, raw materials, intermediates

Desired Candidate Profile:

• Educational Qualification – M.Sc (Organic Chemistry)