M.Pharm

Must be from Formulation Industry. Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non- conforming samples, CAPAs, data evaluation and reporting.

Ability to develop key partnerships internally and externally, influence and negotiate with key personnel, and plan strategically with a systems thinking approach.

To plan and execute various development trials for the allocated project in formulation laboratory along with online recording of experiments and data compilation. To carry out stability studies of projects as per the project requirement and regulatory guidelines.

Study Preparation and Regulatory Compliance, Site management. Documentation and Reporting, Adverse Event Management and Pharmacovigilance, Reporting suspected adverse drug reactions as per pharmacovigilance requirements, ensuring timely submission of SAE reports to ethics committees and regulatory authorities.

Ph.D., Masters degree, Bachelors Degree with First class in all the preceding degrees in the appropriate branch, with an exemplary academic record throughout.

Provides inputs for selection of the equipment Estimates the batch size based on available equipment at the receiving site. Assists in evaluating the suitability of partners development, manufacturing facility for technology transfer.

Experience in oral solid dosage Manufacturing, CVC Packaging. Exposure to Granulation, Compressioa Cooting and Bottle Packaging.

Responsible to monitors activities at clinical study sites to assure adherence to Good Clinical Practices GCPs, Standard Operating Procedures, and study protocols under supervision of Clinical Operations Manager, Clinical Research Specialist.

Compilation and review of product license applications, variations, and renewals for Mexico or ASEAN countries as per regulatory requirements respectively with minimal supervision. Manages electronic documents and creates electronic submissions in CTD format.