Are you an experienced Quality Assurance Specialist with a strong history of facing Regulatory and both Internal and External Audits?

Do you enjoy ensuring that systems and documentation are Audit ready at all times?

Then this role at my client, a world leading Medical Device manufacturer, could be for you.

What's in it for you?

On offer is a full time, permanent position at a leading employer in the region. You will get to grow your career and influence the Quality Systems Management for the site and own the Audit Readiness function. This is a high visibility role with great responsibility and great recognition. As a career move it could set you up for greatness!

About the Job:

• Manage site audit readiness activities across the site ensuring areas are audit ready at all times
• Manage QR’s related to audit findings ensuring implementation of timely and effective corrective actions
• Maintain and update the plant Risk Register
• Represent the site to internal/external Auditors and Regulatory bodies on any matter relating to area of responsibility
• Ensure area of responsibility and processes are audit ready at all times and all audits are supported from a resource and information request perspective
• Act as External audit generalist as required
• Lead and coordinate the audit backrooms during external audits.
• Conduct and own Plant cGMP compliance process
• Build and maintain effective cross functional relationships with all areas of the business.
• Maintain an appropriate balance of quality, compliance, and business risk. Provide compliant yet practical solutions that minimise the impact of Quality issues
• Identify and implement initiatives for continuous improvement of the Quality System
• Ensure effective communication and leadership to management and other staff on compliance issues and site audit preparedness
• Provide divisional level support and guidance as SME for area of responsibility
• Ensure approaches to Quality and Compliance are consistently applied within the business and across the Division
• When requested, accept any responsibilities, and perform any necessary tasks to support the business and other Quality activities

About You:

• Bachelor’s Degree: BSc/BEng scientific, engineering, or related discipline or an equivalent combination of education & work experience
• 3-5 years’ experience in Quality Management Systems & prior experience of the manufacture of regulated products to ensure familiarity with GMP and/or ISO Quality System requirements.
• Experience facing Regulatory Audits and leading a backroom

For more on this and other roles in call Nigel O'Leary on 086 8168273 or email science@hero.ie.
To apply click below.

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.