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Assistant Manager / Manager - FR&D( Formulation Development)

8 - 13 years

10 - 13 Lacs

Bengaluru

Posted:-1 days ago| Platform: Naukri logo

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Skills Required

OSD FR&D Formulation Development Pellets

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for the development and dossier deliverable of genreic application for projects assigned with in the team for Europe ,Canada Australia. Preparation ,review and approval of test licenses Import license applications. Planning and procurement of RMPMs/ RLDs and inventory control at R&D for development. Preparation and review of RMPMs/Justification of Specifications/Cleaning validation report/Risk assessment report/ stability protocol/CDRs/Technology Transfer dossiers. Review of MFRs/BMRs/BPRs/PVPs/HTS, product specific questionnaire, Protocol; and report etc. for scale up and registration batches Timely and Appropriate Reponses for CMC and Bio deficiencies from regulatory agencies for filed products and review of R&D documents for regulatory and quality audits.

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www.medreich.com

Pharmaceutical Manufacturing

Bengaluru

1001-5000 Employees

9 Jobs

    Key People

  • Ravi Shankar Rajan

    Managing Director

  • Kamesh Rao

    CEO

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