Compliance Specialist – Senior-Contract | Collins McNicholas

Compliance Specialist – Senior-Contract

  • Reference: CJ44073
  • Job Type: Contract
  • Location: Limerick, Limerick City, Munster
  • Category: Science, Pharmaceutical & Food

Job Description

The Senior Compliance Specialist will report the Compliance Manager for the site with responsibility for the audit program and for managing the site readiness and the execution of External Inspections.

 

Responsibilities

  • Supports and owns the review and approval of investigations and corrective action plans arising from internal/external audit observations to assure that they meet the required site and MD&D standards of investigations, corrective action plans and effectiveness checks.
  • Responsible for weekly and monthly Reporting of Site Compliance Performance metrics and tracking and trending of the data. Maintains the manufacturing site compliance dashboard for metric reporting.
  • Responsible as a Lead Auditor/Auditor for the execution of Internal Audits in support of the Internal Audit Schedule and report/observation issuance for same where applicable.
  • Responsible for preparing the data for presenting departmental materials for Management Reviews.
  • Supports the creation, deployment, and maintenance of internal audit schedule and approved auditors list.
  • Supports and leads Quality and Compliance projects such as Inspection readiness providing regulatory compliance guidance with regard to some, if not all, of the following areas: medical devices.
  • Responsible for supporting where required the logistical planning for Regulatory Inspections, such as FDA, Notified Bodies and other regulatory inspections.
  • Supports programs for the on-going monitoring and improvement of the effectiveness of the Quality System.
  • Promotes a culture of Regulatory Compliance and Risk Management throughout the organization. Supports departmental and franchise objectives, while adhering to the company Credo, as well as local safety and environmental policy and procedures

 

Education and Experience

Essential

  • Bachelor’s Degree – Scientific or Engineering Discipline or equivalent related experience (RAC certification, ASQ – CQA, CQE or SCQE).
  • Qualified Quality Lead Assessor and experienced auditor in a Quality regulated environment.
  • Minimum of 4 years of working experience in the quality assurance / compliance audit environment required
  • Strong knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments. Experience in managing and implementing robust Corrective and Preventive Action Systems.

Desirable

  • 6+ years of quality assurance/compliance preferred.
  • Experience managing External Regulatory/Notified Body Inspections (e.g. FDA, Anvisa, Florida DoH, BSi etc.) Ability to influence change.
  • Experience with MDSAP certification process would be an advantage
  • Experience with Combination Product Regulations and auditing of same would be a distinct advantage

 

For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email aisling.lane@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

  • Aisling Lane
  • Recruitment Administrator
  • 021 4809118
  • Connect with Aisling
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