Pharmaceutical & Biotechnology

QA Specialist

  • Full Time
  • Cork, County Cork, Ireland
  • 42007717

PE Global is currently recruiting for a QA Specialist on behalf of our client based in Cork.


This is a permanent position.

Under general direction of the Quality & Regulatory Manager, you will be primary responsible for quality systems and quality assurance activities, compliance with cGxP’s, in addition support release of finished product and investigations of product related issues and regulatory affairs.

This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate’s responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately



  • Ensures compliance with cGMP’s & Environmental, Health & Safety regulations.
  • Ensure compliance & execute all activities to the company Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA
  • Executes the finished product non-conformance process.
  • Supports document reviews to ensure timely release of finished product.
  • Executes all regulatory updates to product labelling to ensure timely & compliant launch of finished products.
  • Manages & executes all routine regulatory updates & submissions of finished product labelling.
  • Creation and maintenance of National Drug Codes (NDC) & Universal Product Codes (UPC)
  • Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.
  • Ensures the company and product is registered in the appropriate markets & with agencies as required.
  • Reviews and approves product labeling, patient package insert and other product labeling.
  • Review and approve supplier quality documents.
  • Executes the document control system & record retention.
  • Develops, implements and maintains Standard Operating Procedures.
  • Measure key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement.
  • Maintain familiarity with current regulatory trends.
  • Establishes and promotes the maintenance of a safe, accident free and healthy work environment.
  • Performs related duties as assigned.


  • Minimum requirement of a BSc in a scientific discipline
  • Minimum of five (5) years in a cGMP facility in a Quality Assurance role.
  • Essential to have good communication and attention to detail.
  • Experience in the Pharmaceutical industry is essential.
  • Experience in Medical Device regulations is desirable but not essential.
  • Ability to apply critical thinking on review of all quality related procedures and documents
  • Artwork review/Regulatory experience desirable
  • Supplier Quality
  • Quality Systems
  • Excellent knowledge of Quality Systems, Quality Assurance, cGxP and regulatory affairs.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on +353 860200448 or alternatively send an up to date CV to

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***