Posted:1 hour ago|
Platform:
Work from Office
Full Time
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.
Tiefenbacher Group
Upload Resume
Drag or click to upload
Your data is secure with us, protected by advanced encryption.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.
Instantly access job listings, apply easily, and track applications.
7.0 - 14.0 Lacs P.A.
bengaluru
4.75 - 5.0 Lacs P.A.
greater noida
0.5 - 1.5 Lacs P.A.
mahemdāvād
Experience: Not specified
4.8 - 6.0 Lacs P.A.
noida
15.0 - 24.0 Lacs P.A.
bengaluru, karnataka, india
Salary: Not disclosed
hyderabad, gaddapotharam
10.0 - 15.0 Lacs P.A.
hyderabad, gaddapotharam
12.0 - 17.0 Lacs P.A.
10.0 - 20.0 Lacs P.A.
hosur, tamil nadu
10.0 - 12.0 Lacs P.A.
