Assistant Manager - Regulatory Affairs IMPRONICS DIGITECH PRIVATE LIMITED

4.0 - 8.0 years

0 Lacs

maharashtra

On-site

Role Overview: As an experienced Regulatory Affairs Specialist with a strong educational background in M. Pharmacy, you will be responsible for various key activities related to regulatory affairs in the pharmaceutical industry. Your expertise in regulatory activities such as CTD dossier preparation, query solving, and thorough knowledge of ICH guidelines will be crucial for the successful submission of dossiers to regulatory authorities. Key Responsibilities: - Prepare and submit new dossiers in compliance with regulatory requirements - Conduct gap analysis of dossiers to ensure completeness - Compile dossiers in eCTD format for submission to regulatory authorities - Coordinate the submissi...

Posted 3 weeks ago

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QA Sterile Manager Sun Pharmaceutical Industries Ltd

10.0 - 14.0 years

0 Lacs

dewas, madhya pradesh

On-site

You will be joining Sun Pharmaceutical Industries Ltd as a QA Sterile Manager in the Quality Assurance department. Your role will involve managing the Quality Assurance functions of the Manufacturing Block P. As the Manager-I, you are required to hold an M.Sc. degree in Biotechnology, Microbiology, or Chemistry with over 10 years of experience in the field. Your responsibilities will include ensuring that manufacturing and packing processes are carried out per SOPs and cGMP regulations. You will be responsible for certifying batch production records, releasing/rejecting batches after thorough reviews, and tracking the QMS system. It will be your duty to investigate complaints, deviations, OO...

Posted 1 month ago

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Assistant Manager QA/QC 91HR

5.0 - 9.0 years

0 Lacs

maharashtra

On-site

As an Assistant Manager/Manager- Quality Assurance, your responsibilities will include: - Reviewing and approving Standard Operation Procedures (SOP's) for all departments, ensuring timely completion of reviews and revisions according to the specified revision date. - Evaluating and approving analytical method validation protocols and reports, process method validation protocols and reports, water system validation protocols and reports, as well as equipment/instrument qualification protocols and reports. - Reviewing and approving raw material, packing material, semi-finished product, and final product specifications and test methods for analysis. Approving artwork and shade cards for printe...

Posted 2 months ago

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Quality Head Assistant-QA & QC Manager Ankit Pulps & Boards Pvt. Ltd.

6.0 - 10.0 years

0 Lacs

nagpur, maharashtra

On-site

You will be responsible for reviewing the implementation and maintenance of the Quality Management System in compliance with regulations. This includes determining, negotiating, and agreeing on in-house quality procedures, standards, and specifications. You will be tasked with checking and maintaining Master Documents related to the QMS system. Additionally, you will review filled Batch Production control records and analysis reports for batch release. Your role will involve coordinating validation activities and validation protocols, as well as controlling and approving deviations raised in the concerned department while recording them. You will also review and approve standard operating pr...

Posted 3 months ago

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