23 Aug
|
Daffodil Pharmachem
|
Kadi
23 Aug
Daffodil Pharmachem
Kadi
Role & responsibilities
Lead and manage QC laboratory operations for biotechnology and fermentation processes.
Oversee testing of raw materials, media, fermentation broth, intermediates, and finished products.
Monitor fermentation parameters and in-process quality attributes in coordination with Production/Process teams.
Manage microbiological testing, including microbial identification, bioburden, contamination monitoring, and sterility-related testing.
Oversee biochemical and analytical testing such as pH, moisture, protein, assay, biomass, and other product-specific parameters.
Ensure proper sampling, testing, documentation, and release of materials and products.
Handle OOS, OOT, deviations, investigations, CAPA, and change controls related to QC.
Establish and review specifications, analytical methods, SOPs, protocols, and test procedures.
Ensure qualification, calibration, and maintenance of laboratory equipment.
Ensure compliance with GMP, GLP, biosafety, data integrity, and ALCOA+ principles.
Lead method validation, verification,
analytical method transfer, and process-related testing.
Prepare and coordinate the QC function for internal, customer, and regulatory audits.
Manage QC personnel, training, workload, and laboratory performance.
Coordinate closely with Production, QA, R&D;, Fermentation, and Process Development teams.
Preferred candidate profile
Solid experience in Biotechnology / Fermentation QC.
Knowledge of Microbiology and Fermentation Technology.
Experience with microbial culture, contamination control, media testing, and microbial analysis.
Knowledge of HPLC, GC, UV-Vis, FTIR, pH meter, spectrophotometer, and other relevant analytical instruments.
Understanding of fermentation process monitoring and in-process controls.
Knowledge of GMP, GLP, OOS/OOT, CAPA, deviations, and data integrity.
Experience in laboratory documentation and regulatory compliance.
Solid team management, troubleshooting, and pr
📌 Qc Manager Kadi
🏢 Daffodil Pharmachem
📍 Kadi