Assistant General Manager Formulation Development (Injectable) Intas Pharmaceuticals

16.0 - 22.0 years

0 Lacs

ahmedabad, gujarat

On-site

As an Assistant General Manager (AGM) Formulation Development specializing in Injectable dosage forms, you will be responsible for the development, scale-up, and validation of both simple and complex formulations for Injectable products. Your primary focus will be on creating dosage forms compliant with regulations in the US, EU, India, Canada, Brazil, and other markets. Your key responsibilities will include: - Developing Injectable dosage forms for various global markets - Scaling up and transferring technology for Injectable products across different regions - Designing formulation strategies and overseeing the drug product development roadmap - Reviewing stability data of products under development and during validation batches - Handling regulatory queries and conducting studies as necessary - Coordinating with internal departments and external vendors for drug product development - Troubleshooting product and process failures, particularly for US, EU, and other markets - Providing technical guidance to subordinates and ensuring compliance with laboratory practices and safety regulations - Following Good Documentation Practices and Data Integrity requirements during GxP operations - Ensuring understanding and adherence to Data Integrity requirements and consequences - Reviewing data for compliance with Data Integrity requirements in the context of job responsibilities Your role will be crucial in ensuring the successful development and validation of Injectable dosage forms for multiple markets, requiring strong technical expertise, regulatory knowledge, and attention to detail.,

Posted 5 days ago

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Assistant General Manager Formulation Development Intas Pharmaceuticals

16.0 - 22.0 years

0 Lacs

ahmedabad, gujarat

On-site

As an Assistant General Manager (AGM) in Formulation Development for Injectable products, you will be responsible for the development, scale-up, and validation of simple and complex Injectable dosage forms for various markets including US, EU, India, Canada, Brazil, and others. This role is based at the Matoda plant in Ahmedabad. Your key responsibilities will include: - Developing Injectable dosage forms for multiple markets - Scaling up and transferring technology for Injectable dosage forms - Designing formulation strategies and drug product development roadmaps - Reviewing trials processes, development records, and technology transfer documents - Analyzing stability data of products under development and validation batches - Handling regulatory queries and conducting studies as required - Organizing resources, facilitating communication, and coordinating timely drug product development with internal departments and external vendors - Troubleshooting product issues and actively participating in failure investigations - Providing technical guidance to subordinates and ensuring adherence to good laboratory practices and safety regulations - Following Good Documentation Practices and Data Integrity requirements during all GxP operations - Ensuring understanding and application of Data Integrity requirements and consequences for non-compliance - Reviewing GxP data in compliance with Data Integrity requirements specific to the job description You may also be required to perform any other activities designated by your supervisor to support the overall objectives of the organization.,

Posted 2 weeks ago

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