SGS Quality Assurance – Limerick | Collins McNicholas

SGS Quality Assurance – Limerick

  • 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.

 

Minimum Qualifications                               

  • 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 emer.ocallaghan@collinsmcnicholas.ie

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

Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!

 


Firstname (required)

Surname (required)

Your Email (required)

Your phone

Upload CV (required)

Security Code captcha

Comment

Contact Consultant

  • Emer O'Callaghan
  • Recruitment Consultant
  • 0214911061
  • Connect with Emer
Request a Call Back

The Year in Recruitment 2016

Calendar
2016 was another good year for job growth in Ireland. Over the course of the year, unemployment dropped from 8.9% to 7.2%, to reach an eight year low. Foreign Investment IDA Ireland companies performed very well in 2016, with employment by overseas companies almost reaching the 200,000 mark. These companies created just under 19,000 jobs […]
read whole article

Time to Make a New Year Career Resolution

Happy New Year 2017
Like most people I make new year’s resolutions, and like most people by the end of January they lie in ruins. The changes I so desired to make just a few weeks earlier have failed to materialise as I let myself slip back into old habits, consoling myself with the thought that I was being […]
read whole article

Job Seekers Guide

cmcn_hr_color
Everything you need to know to find a job, including; how to prepare a CV and cover letter, how to prepare for a job interview, how to navigate the modern job market, and much more.
view more