29 Edqm Jobs - Page 2

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4 - 9 years

30 - 32 Lacs

Bengaluru

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About The Role : Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Se...

Posted 5 months ago

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5 - 8 years

7 - 10 Lacs

Hyderabad

Work from Office

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or ...

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5.0 - 10.0 years

5 - 12 Lacs

aurangabad

Work from Office

Hi, We have opening for the position of API regulatory affairs department for API Manufacturing industry. Role & responsibilities 1. Compilation and submission of Drug Master File (DMF) to USFDA, EDQM, Health Canada, Australia, China, Japan, Brazil and for EU countries 2. Submission of DMF amendments and variation filings to implement the post approval changes 3. Evaluation of change controls and perform regulatory assessment based on submitted DMF 4. Co-ordinated with cross functional team such as QA, QC,production, ADL and R&D and review of documents received for registration purpose. 5. To Maintain regulatory database by following best regulatory practices 6. To prepare action plan for De...

Posted Date not available

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5.0 - 10.0 years

7 - 12 Lacs

ahmedabad

Work from Office

Candidate should have fair knowledge of API & Formulation Stores functions. RM/PM Receipt, Storage, Material Issuance, Dispatch etc. Experience of regulatory audits like - USFDS, EDQM, PMDA etc. QMS related documents & Compliance. Statutory requirements of MA-1, MA-2, RS-2, AC-2, DS-5 and monthly returns, Quarterly returns, Yearly returns etc. Inventory Planning and accountability, stock requirements, material movement, hazardous material handling, tanker unloading etc.

Posted Date not available

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