QA Validation Associate

PSC Biotech is a leading Biotech Consultancy firm seeking a QA Validation Associate to provide quality oversight for validation activities in a GMP regulated environment, incorporating implementation, requalification and decommissioning of manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.

Requirements

• Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences)
• +3 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems/validation
• Organizational and management skills to coordinate multi-discipline project groups
• Ability to speak, present data, and defend approaches in front of audiences and inspectors
• Ability to comprehend technical information related to equipment, processes, and regulatory expectations
• Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations
• Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred