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    CAPA (Corrective Action/Preventative Action) Manager

 

The position is directed at enabling complaint investigation, nonconforming product investigation, and phase 2 out of specification investigation (Phase 2 OOS) within the organization for CAPA, continual /improvement, and/or cost savings.  Leads and provides technical support on each project and with each team comprised of Quality Assurance and process owners for root cause investigation, continual improvement and CAPA investigation.  Responsible for assuring each project team identifies CAPA in a timely fashion, documents CAPA activities in accordance with FDA regulations, and trends CAPAs for management review and preventive action. Coordinate the effective completion of all CAPAs, Complaints, Nonconformance’s, Internal Audits and Investigations

Job Description:

  • Manage the CAPA Program, including the investigation of all sources of CAPA from complaints, nonconforming material, deviation reports, and third party/internal audits observations. 
  • Assure the CAPA procedures and processes conform to US Food and Drug Administration and Global regulations and standards.
  • Coordinate CAPA Review Board Meetings for the management approval of CAPA requests, results of root cause and CAPA investigations, CAPA effectiveness check plans and CAPA data.
  • Drive execution of CAPA and Continual Improvement Process.
  • Coordinate and facilitate CAPA project leaders/multifunctional teams in the timely and complete investigation of root cause for complaints, nonconforming material, deviation reports, and third party/internal audit observations. 
  • Coordinate and facilitate project leaders/multifunctional teams in the timely and complete investigation of CAPA actions and verification of CAPA effectiveness. 
  • Establish required documentation for complaint, nonconforming material, deviation report files, and third party and audit observation files. 
  • Establish strategic direction for CAPA and continual improvement activities that are aligned with business and quality initiatives and in compliance with all regulatory requirements.
  • Responsible for overseeing and/or performing auditing efforts that seek to ensure compliance
  • Analyze CAPA trends to monitor the effectiveness of the CAPA process and drive remediation for improvement.
  • Plan, design, and implement a compliance audit schedule to identify and resolve major risk areas and provide management over compliance-focused efforts.
  • Performing risk assessments on key business activities and using this information to guide what to cover in audits;
  • Prepare Management Review reports on complaints, nonconforming material, deviation reports, and third party/internal audit observations.

Qualifications:

  • Education:  Bachelor Degree in Engineering, Quality Engineering or a Life Science.
  • Experience:  Five (5) years’ experience in quality assurance/quality engineering in the pharmaceutical or medical device industry preferred.   
  • Knowledge of FDA 21CFR211, 21CFR820, ISO and related guidance documents.
  • Project management skills.
  • Computer Skills – Minitab, Microsoft Excel, Word, Power Point, and Adobe Acrobat.