Quality & Regulatory Specialist

Science & Pharmaceutical
Science & Pharmaceutical
Cork
Permanent
16193
Cork
Permanent
16193

Reporting to 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 products.


Role Responsibilities:

  • Ensures compliance with cGMP's & Environmental, Health & Safety regulations.
  • Ensure compliance & execute all activities to the BluePoint Laboratories 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.
  • 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.

Role Requirements:

  • BSc in a scientific discipline (or equivalent plus experience); minimum of 3-5 years in a cGMP facility in a Quality Systems/Quality Assurance Operations role. 
  • Essential to have good communication and attention to detail.
  • Experience in the Pharmaceutical industry is essential.  
  • Excellent knowledge of Quality Systems, Quality Assurance, and cGxP.

For a confidential discussion and more information on the role, please contact Josh Barnes.

josh.barnes@collinsmcnicholas.ie

021-4911066

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Josh Barnes
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