- Reference: CJ43541
- Job Type: Contract
- Location: Limerick, Limerick city, Munster
- Category: Science, Pharmaceutical & Food
Job Description: The Senior Specialist, CAPA will be primarily responsible for the oversight of the CAPA process and procedures, and ensure it is compliant, effective and efficient in dealing with quality issues. The Senior Specialist, CAPA will, through expertise in problem solving methodology, facilitate proactive and effective resolution of issues.
- 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 Internal, Corporate and third party compliance audits.
- 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. Up to 50%
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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