3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

You will be responsible for: - Handling Quality Management System (QMS) for drug substance of bacterial products - Demonstrating good process understanding of upstream and downstream unit operations - Managing QMS documents including deviation, change control, and investigations through Track-wise software - Ensuring audit compliance and adherence to regulatory guidelines - Knowledge on documentation such as Standard Operating Procedures (SOP) and Batch Manufacturing Record (BMR) preparation Qualifications required: - Experience range of 3 years to 6 years in a similar role,

Posted 5 days ago

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AGM / Sr. Manager - Regulatroy Affairs NMS Consultant

0.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Role & responsibilities : Reviewing, verifying, and processing of all technical documents for accuracy before compilation or submission of dossiers as per USFDA & PEPFAR requirements. Review and regulatory compliance of Initial ANDA Documents like Trade dress, Q1 and Q2, bio-wavier, IIG clearance, MDD evaluation, Size and Shape, Elemental iron, Residual solvent, Elemental impurity and Exactable and Leachable impurity, Specifications [API and Finished drug Product), Master Formula (with respect to Bio-waiver), Stability Protocol, Labeling Information, Product development Report, Method Validation Report, BMR and BPR etc. Participate and represent as regulatory team in meetings (Level 1 and 2 ...

Posted 2 weeks ago

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Officer/Executive-QA Zydus Group

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a member of the VTC MFG. QA team, your role will involve handling the Quality Management System (QMS) for drug substance of bacterial products. You are expected to have a strong understanding of the processes involved in both upstream and downstream unit operations. Your responsibilities will include: - Managing QMS documents including deviations, change controls, and investigations using Track-wise software. - Ensuring audit compliance and adherence to regulatory guidelines. - Proficiency in documentation tasks such as Standard Operating Procedure (SOP) development and Batch Manufacturing Record (BMR) preparation. Qualifications required for this role include: - A minimum of 3 to 6 years...

Posted 2 months ago

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