CSBio
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Biotech • Pharmaceutical • Industrial • Manufacturing
Lead and support the Quality Management System for cGMP peptide manufacturing: manage deviations, CAPAs, OOS, document control, training, validation (IQ/OQ/PQ), risk assessments, complaint handling, recalls, continuous improvement, and staff development to ensure regulatory compliance and product quality.
Biotech • Pharmaceutical • Industrial • Manufacturing
Lead and scale cGMP peptide manufacturing operations including SPPS, purification, lyophilization, and packaging. Manage a small production team, production scheduling, equipment qualification, batch documentation, investigations, tech transfers, and regulatory data packages to ensure on-time delivery, product quality, and regulatory compliance.
