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8.0 - 10.0 years
0 Lacs
guwahati, assam, india
On-site
Role Summary: The incumbent will be responsible for managing end-to-end Quality Control activities at the factory, ensuring robust quality systems, zero-defect culture, and compliance with internal and regulatory standards. Key Responsibilities: Ensure standard QC procedures for RM/PM/Bulk/FG sampling and release are followed as per AQL, specs & analytical protocols. Audit and manage BPR, IPQC & QC documentation. Implement CAPA for non-conformance. Strengthen in-process checks and support plant teams in incident mapping & resolution. Drive improvement in QACI, QRI & QMS metrics; generate and publish QC MIS reports. Manage disposition of rejected/non-conforming materials and ensure traceabili...
Posted 2 months ago
5.0 - 9.0 years
0 Lacs
navi mumbai, maharashtra
On-site
As a candidate for this role, you will be responsible for the following key responsibilities: - Thorough knowledge of HPLC based analysis of recombinant proteins including RP-HPLC, SE-HPLC, and glycan analysis. - Independently design method development of proteins, qualification, transfer following ICH/USP/EP/IP guidelines. This includes writing and reviewing protocols, transfer plans, and reports. - Carry out day-to-day analytical work and collaborate with the Cell culture and downstream teams in Biotech R&D. - Set up product-related test/release specifications and analytical protocols for Biotech products. - Design in-house/outsource methods for Physico-chemical characterization of biologi...
Posted 3 months ago
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