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Manager

Tiefenbacher Group

8 - 13 years

10 - 15 Lacs

Hyderabad Gaddapotharam

Posted:2 months ago| Platform:

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Skills Required

production Technology Excellence risk assessments FDA quality assurance EMA cGMP technology transfer methodologies Batch Manufacturing Records

Work Mode

Work from Office

Job Type

Full Time

Job Description

Manage the technology transfer process for established products, ensuring robust and compliant manufacturing processes e.g. implementation of new API sources. Write, review, and maintain regulatory response documents, justification reports, and risk assessments related to technology transfer activities. Oversee the preparation and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for smooth transfer and manufacturing. Review process validation protocols and reports. Coordinate with R&D, production, quality assurance, and regulatory teams to ensure alignment on project deliverables and timelines. Troubleshoot and optimize manufacturing processes addressing deviations and improving efficiency. Conduct technical risk assessments to identify and mitigate potential issues during and post-transfer. Maintain comprehensive documentation to ensure compliance with regulatory standards (e.g., FDA, EMA, cGMP) and internal quality guidelines. Stay updated on regulatory trends and industry standards to continuously improve documentation practices and technology transfer methodologies.

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