vacancies

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.

Ensure on time analysis of Finished products and raw materials for required product and projects. Review of analytical data, raw data, daily usage logbooks and Lab notebooks for routine operations for analytical development function. Preparation and review of critical documents like Analytical Method validation protocol, reports, Analytical method transfer protocols and reports.

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.

Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.

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.

Interested candidates are hereby informed to visit the website regularly for individual notifications, recruitment rules, general terms and conditions and instructions for applying and other details carefully before applying their application. 

The minimum educational qualification of the candidate shall be Matriculate or equivalent followed by Diploma m Pharmacy from Govt, recognized Institute. Previous Experience of working as Pharmacist is desirable.