Senior Specialist, CAPA - Cork
Our client, a medical device company in Cork are currently looking to recruit a Senior Specialist, CAPA for their site on a 12 month contract.
Job Description / Information
- Working within the QMS team, under general supervision, ensure compliance to CAPA processes and procedures and is responsible to, but not limited to.
- Have responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity and timeliness. Review & Approval of CAPA changes including extension requests.
- Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC / CAPA process.
- Ensuring users provide the necessary rigor to the eCAPA system content including maintaining a live document with all relevant evidence attached, in a timely manner.
- As Problem Solving Methodology expert, facilitate and coach NC & CAPA teams in the application of problem solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
- Subject Matter Expert on all related procedures, ensuring compliance to the relevant corporate procedures. Super user of eCAPA system.
- Lead & execute the NC/CAPA Review board forums. Lead multi-site forums and participate in global forums.
- Manage & monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, also liaising with other GQO sites to ensure compliance to global requirements & metrics are achieved.
- Ensure adequate training is developed, maintained and provided to all users of CAPA process & systems.
- Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
- Lead &/or participate in cross-plant and corporate project teams in areas of CAPA and quality systems improvement.
- Lead/coordinate preparation, participate and follow up to the company Internal, Corporate and third party compliance audits.
- Engineering/Science license or Engineering diploma (diploma d'ingenieur) required
- Bachelor degree/ Masters of Science, Engineering or equivalent/ related subject required, or
- Technician/Meister degree with 6 years of experience in a quality discipline
- Bachelor degree/ Masters of Science, Engineering or equivalent/ related subject required,
- Minimum of 2 years' experience in area of quality systems or engineering or equivalent experience.
- Minimum of 4 years in regulated environment required.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
- Thorough knowledge and understanding of US and International Medical Device Regulations.
- Strong knowledge of supporting Quality Systems (e.?g.? Audits, Management review, Quality Planning).
- Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
- Strong interpersonal skills.
- Strong written and oral communication and negotiations skills.
- Strong in critical thinking and "outside the box" thinking.
- Highly developed problem solving skills.
- Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently.
- Experience in working in a compliance risk situation.
- Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
- Some travel may be required.?
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