Quality Assurance Specialist

Reporting to the Quality Assurance Director. This role will be responsible for performing key quality tasks in respect of Company products. Working in the Quality Group within the Technical Operations department, which oversees contract manufacturing operations, select supply chain operations and development functions.

The Position

Responsible for developing and maintaining Quality Systems and to ensure that all operations are fully in compliance with current international standards for cGMP.
The individual will be responsible for:

  • Managing the product stability programme.
  • Investigating out-of-specification (OOS) reports & deviations.
  • Act as lead auditor in third party vendor audits, to include: GMP contract manufacturing, analytical testing, and storage locations when required to ensure compliance with company requirements and country specific regulations.
  • Monitor the operations at the Contract Manufacturer. Perform batch review, review product complaints, deviations, change controls and product related investigations.
  • Be a key member of company audit team during regulatory or customer audits.
  • Operate the CAPA system.
  • Develop and write SOPs & controlled documents.
  • Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.
  • Report Quality Metrics.
  • Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA’s).

The Person

The successful incumbent will have a Bachelors degree in Chemistry, Biology or related discipline. The ideal candidate will have experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas. Thorough understanding of quality systems and cGMP’s is essential as well.

To learn more apply online or contact Preneta Naidoo on +353 1 6321870.

Salary: On Application Location: Dublin City Centre