Connecting...

QA Specialist 60k

Job description

My client a Cork Waterford Medical company requires a QA Engineering Specialist

This individual will be a key member of the QA Audit & Compliance team

Key duties of this role include (but not limited to) :

  • Ensuring all QSE Management System procedures and records are reviewed & authorised.
  • Work with Regulatory Affairs/Legal Manufacturer reps to identify requirements to ensure :
  • All manufacturing location validation and processes meet legislation 2017/745 (MDR) requirements.
  • Providing assistance and support in the preparation and maintenance of the QSE site manuals.
  • Ensure all documents are in line of the ISO 9001, OHSAS 18001, ISO 50001 standards.
  • Preparing & participating in external audits conducted by the DOE, EPA, HSA ETC..
  • Providing constructive evaluation of quality related systems from suppliers.
  • Suppliers can include API, contract labs, excipient suppliers, commodity / logistics suppliers etc.. 
  • Major responsibilities include.
  • Assess compliance of systems, facilities, and procedures per applicable regulations.
  • Perform audits & assessments of suppliers, assuring compliance to reg requirements.
  • Provide feedback in the form of audit observations, and review corrective actions (CAPA's).
  • Participate in strategic initiatives to improve compliance to reg requirements and standards.
  • Education & Experience :
  • Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology etc.
  • Knowledge of technical standards & regulatory requirements for Europe, USFDA, a distinct advantage.
  • At least 2 years) with sufficient exposure to pharmaceutical, medical device, or combination of.
  • Must have a technical background & understanding of the audit process.
  • Knowledge of worldwide requirements related to GMP regulations for quality systems & compliance.
  • Understands a variety of quality/operational systems that support facility, product design etc.. 

An excellent salary is on offer.

For more information please mail codonnell@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.