Jobs → Project Management → C&Q Project Manager

C&Q Project Manager

Varalakshmi ChagantiUnited StatesMIDPosted 7d ago
PharmaceuticalBiotechC&Q/CQVProject managementGMP qualification documentationProcess equipmentClean utilitiesHVACGMP-critical systems
About the Role We are seeking a C&Q Project Manager to lead Commissioning & Qualification project activities in the pharmaceutical and biotech industry. This role involves managing the qualification of manufacturing equipment, facilities, utilities, and process systems while ensuring compliance with regulations. Key Responsibilities • Lead Commissioning & Qualification (C&Q/CQV) project activities • Manage qualification of pharmaceutical manufacturing equipment, facilities, utilities, and process systems • Review and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation • Coordinate with Engineering, Validation, QA, Automation, and Manufacturing teams • Ensure compliance with cGMP, FDA regulations, ASTM E2500, and ISPE guidelines • Manage project schedules, resources, risks, vendors, and project deliverables • Support deviation management, change control, CAPA, and audit readiness Requirements • Pharmaceutical or Biotech C&Q/CQV experience • Project management or team leadership experience • Strong knowledge of GMP qualification documentation • Experience with process equipment, clean utilities, HVAC, or GMP-critical systems • Excellent communication and documentation skills

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