Research Associate-FD

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Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Research Associate-FDJob Description

Handles formulation development for NCE, generic, and line extension projects, including documentation, GMP batch execution, scale-up, and technology transfer. Ensures compliance with GxP, QMS, and EHS requirements, supports audits, cross-functional communication, training, and contributes to project and operational needs.
• Formulation development of NCE projects, generic projects and line extension projects
• Preparation/review of literature summary and development report to the assigned product.
• Involve in execution and/or supervision of formulation development, process development and manufacturing of GMP batches of assigned product.
• Preparation/review of technical documents, which includes but not limited to MFC, BMR, BPR and Stability protocol following GDP.
• Representation in departmental audit
• Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
• Execution and/or supervision of scale up/pilot scale batches in pilot plant under GMP condition.
• Preparation and/or review of technology transfer documents and technology transfer to manufacturing site, whenever required.
• Preparing/reviewing of QMS includes but not limited to change control, deviation, SOPs and OOS
• Communication with cross-functional team and client via mails, meetings and oral communication
• Provide training on but not limited to SOPs, technology, guidelines and project specific activities
• Performing and/or supervision calibration and maintenance of R&D instruments and equipment
• Procuring materials and machines change parts related to concern projects
• Maintain safe and hygienic condition in respective department
• Ensuring the use of personal protective equipment whenever required during batch execution
• Attending training related to FD, EHS, QA or any other department (if applicable)
• Ensure comply with EHS requirements while working in FD lab and Pilot plant.
• Support to proposal preparation for upcoming new projects
• Support to any additional responsibility/activity within or other department as and when required

Master of Pharmacy (M.Pharm)