Plant QA Manager 24/7

Plant QA Manager Responsibilities
• Responsible for leading and directing a team on 24/7 shift including managing their performance and supporting their development.
• Provide real-time QA oversight and support for production operations. This currently extends to formulation, vial and Syringe Fill Finish aseptic operations and visual inspection.
• Collaborate with operations to resolve quality and compliance issues, including but not limited to Change Controls, NCs and CAPAs.
• Ensures that changes that could potentially impact product quality are assessed according to procedures (ex: site change control, maximo)
• Review and approve cGMP records (e.g., Non Conformances, CAPA’s, electronic batch record, change controls, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation
• Alerts senior management of quality, compliance, supply and safety risks
• Support and represent Quality during audits and inspections
• Support Lean Transform...