Quality Expert in Pharmaceutical Industry

2 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €71,258 - €90,134

Are you a seasoned quality expert looking to take on a challenging role in the pharmaceutical industry?

This exciting opportunity is with a leading multinational organization based in Dublin, Ireland. As a Quality Assurance Specialist, you will play a key part in ensuring that our products meet the highest regulatory standards.

About the Role

We are seeking a highly experienced and skilled individual to join our team as a Quality Assurance Specialist. In this role, you will be responsible for acting as the quality point of contact and decision maker during new product introductions, technology transfer, and process validation activities for aseptic products.

You will also be responsible for reviewing and approving process development and validation documentation, providing quality direction and input at change control and deviation review boards, and assuming QA oversight of change control and deviation/CAPA records.

  • Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet regulatory expectations.
  • Quality review and approval of Process Development and Validation documentation.
  • Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
Requirements

To be successful in this role, you will need to have a Bachelor's degree in a scientific or engineering field and 7+ years of experience working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas.

You will also need to have a strong understanding of principles of validation and new product introduction, as well as experience in aseptic manufacturing.

  • Bachelor degree, in a scientific or engineering field.
  • 7yrs+ working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
  • Understanding of principles of Validation and New Product Introduction.
  • Experience in aseptic manufacturing.
Benefits

We offer a competitive salary and benefits package, including opportunities for professional growth and development. You will work in a dynamic and collaborative environment with a team of experienced professionals who are passionate about delivering high-quality products.

What We Offer

We offer a range of benefits, including:

  • A competitive salary.
  • A comprehensive benefits package.
  • Opportunities for professional growth and development.

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