Qc Manager

Daffodil Pharmachem; Kadi; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Daffodil Pharmachem in India is seeking a results-driven QC Laboratory Manager to lead and manage QC operations for biotechnology and fermentation processes. You will oversee testing of materials from raw inputs to finished products and coordinate with Production and Process teams to ensure quality at every stage.

The role requires strong microbiology knowledge, GMP/GLP compliance, and hands-on experience with analytical methods and equipment such as HPLC, GC, UV-Vis, FTIR, and pH meters.

Qualifications

• Biotechnology/ Fermentation QC experience required.
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Responsibilities

• Lead and manage QC laboratory operations for biotech and fermentation processes.
• Oversee testing of raw materials, media, fermentation broth, intermediates, and finished products.
• Monitor fermentation parameters and in-process quality attributes.
• Manage microbiological testing, including microbial identification, bioburden, and sterility-related testing.
• Oversee biochemical and analytical testing such as pH, moisture, protein, assay, biomass.
• Ensure proper sampling, testing, documentation, and release of materials and products.
• Handle OOS, OOT, deviations, investigations, CAPA, and change controls.
• Establish and review specifications, analytical methods, SOPs, protocols, and test procedures.
• Coordinate with Production, QA, R&D, Fermentation, and Process Development teams.

Skills

Biotech QC

Fermentation QC

Microbiology

GMP/GLP

Data integrity

Team management

Troubleshooting

Analytical instruments

Tools

HPLC

GC

UV-Vis

FTIR

pH meter

Spectrophotometer

Job description

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

• Strong 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 problem-solving skills.