Manager QA

Being in this role at the Quality team, you will be responsible for leading and directing Quality staff supporting production in the shift, including managing their performance and supporting their development.

The Manager QA is also responsible for providing guidance and direction to Production, Maintenance & Engineering, and Quality staff regarding compliance with quality standards and procedures. Optional, but not a requirement, you will be fulfilling the duties as a Qualified Person.

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In this vital role, you will:

• Manage resource planning (e.g. shift roster, holidays) per business need
• Responsible for achieving Plant QA Key Performance Indicators
• Provide real-time QA oversight and support for production operations.
• Collaborate with operations to resolve quality and compliance issues. You will lead and assist in various investigations as needed.
• Review and approve cGMP records (e.g., Deviations, 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
• Participate in internal audits and lead as appropriate, and in regulatory inspections and partner audits.
• Support Lean Transformation and Operational Excellence initiatives, drives continuous improvement initiatives within Plant QA, and drive together with production management reduction of repeating events within Plant QA and production.
• Provides training and advice to staff in order for them to perform their desired functions.
• Understand the interaction between batch review activities and batch disposition and align with PQA QP’s to enable batch disposition within agreed timelines.
• Optional: Execute batch disposition