22 Aug
|
Daffodil Pharmachem
|
Kadi
22 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.
- Strong team management, troubleshooting, and pr
📌 Qc Manager (Kadi)
🏢 Daffodil Pharmachem
📍 Kadi