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5.0 - 7.0 years
0 Lacs
hyderabad, telangana, india
On-site
Summary The Purpose of the Specialist role is having expertise in Extractables and Leachables assessment, work in close collaboration with multiple functions such as MS&T, Supplier management, Regulatory, toxicology, Procurement, Quality and Production. The individual plays a key role in support of Extractable and Leachable activities with a strong focus on data collection, Risk rating, assessments and evaluation. About The Role Key Responsibilities: Understanding of Extractable and Leachable (E&L) risk assessment for materials based on supplier information and the ability to determine the risk level and update the Risk assessment. Building a comprehensive material library backed by correspo...
Posted 1 week ago
5.0 - 9.0 years
0 Lacs
hyderabad, telangana
On-site
The Purpose of the Specialist role is to have expertise in Extractables and Leachables assessment and work closely with multiple functions such as MS&T, Supplier management, Regulatory, toxicology, Procurement, Quality, and Production. You will play a key role in supporting Extractable and Leachable activities with a strong focus on data collection, Risk rating, assessments, and evaluation. Key Responsibilities: - Understand Extractable and Leachable (E&L) risk assessment for materials based on supplier information and determine the risk level - Build a comprehensive material library backed by corresponding E&L test data - Manage the coordination for Extractables studies or product-specific ...
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
hyderabad, telangana
On-site
As a Specialist in the Site MS&T team within the Large Molecules Platform at Novartis Healthcare Private Limited in Hyderabad, India, you will work closely with multifunctional technical operations teams. Your role involves executing and supporting Technical Transfers and Life Cycle Management activities, with a strong emphasis on preparing and updating Risk assessments and Validation related documentation. Key Responsibilities: - Utilize Validation and Life Cycle Management Expertise to prepare process and cleaning validation documentation, conduct change evaluations, and ensure compliance with cGMP requirements - Support process validation lifecycle activities and participate in pre-valida...
Posted 2 months ago
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