Evaluates and progress the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, and/or deviations, as output from the division’s Quality System.
Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.
Supports the attainment of division goals and objectives.
Accountable to the Quality Organization for achieving mutually agreed upon objectives.
Supports other organizations in the management of their CAPA actions and provide additional confidence that investigations are initiated and completed in a complete, concise, and timely manner; and that viable corrective actions are identified and implemented to address any non-conformances.
The CAPA System is a key inspection focus of worldwide regulators and auditors.
The system must be usable, simple, sustainable and well maintained.
Failure to comply with the primary objectives of this role can result in negative impact to the business such as observations, warning letters, de-certification, or product recalls.
Decisions and recommendations made by this position impact quality decisions for marketed products and the division’s Quality System.
QUALIFICATIONS
Minimum of an Associates Degree or Bachelors Degree Preferred
EXPERIENCE/BACKGROUND
Minimum of two (2) years of experience working in a regulated environment or experience performing investigations.
Knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 is preferred.
Able to apply strategic and quality logic and project management skills to investigation activities ensuring appropriate investigations are conducted.
Good project management skills to deliver an effective service in a timely manner.
Attention to detail to ensure accuracy of work that forms part of the Quality System documentation.
Good written and oral communication skills to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization.