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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 week ago
5.0 - 7.0 years
4 - 8 Lacs
hyderabad
Work from Office
Responsible to prepare protocols ,reports, Sop's, review docs and analysis, methods development, verification validations for AET,MLT Sterility test& BET, follow GMP&GLP,SILUTION STUDY/microbial ingress study.
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
telangana
On-site
You will be responsible for managing all Quality Management System (QMS) activities related to production. It is crucial to ensure that batch charging and other manufacturing operations strictly adhere to the Batch Manufacturing Record (BMR) and Standard Operating Procedures (SOP), aligning with current Good Manufacturing Practices (GMP). Your duties will include maintaining manufacturing records online, collecting samples of intermediate materials, entering production-related data into the SAP system, and verifying the generation of PISCADA reports. Additionally, you will be tasked with overseeing finished goods transfer, monitoring stock levels of consumables, coordinating with various ser...
Posted 3 months ago
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