QA Specialist 60k

Job description

My client a Tipperary 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.

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