Qualified Person

1 week ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €75,000 - €90,000
Job Title: Qualified Person - Regulatory Compliance Specialist In our single-use multi-product biotech facility, we are seeking an experienced Regulatory Compliance Specialist to join our Quality Assurance Team. Job Description:

We require a highly skilled professional to perform Qualified Person duties, ensuring the certification of batches for release in accordance with EC Directives and EU Guide to Good Manufacturing Practice.

  1. Perform Qualified Person duties in certifying batches for release in accordance with relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
  2. Ensure batch manufacturing and testing comply with cGMP and relevant marketing authorization (MA) or clinical trial authorization, product specification file, legal obligations, and/or technical agreement.
  3. Manage and escalate potential CGMP and other concerns in a timely manner.
  4. Provide oversight of deviations, including approval of significant deviations, and laboratory investigations related to drug substance manufacture, testing, and those that may present potential effect on product and/or material.
  5. Confirm change requests with product impact requiring expanded review have been appropriately reviewed, approved, and technically closed.
Required Skills and Qualifications:
  • EU QP qualification and experience (at least 5 years) of certifying batches for release in accordance with relevant EC Directives including 2001/83/EC, Annex 16, and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
  • Expert level of knowledge of relevant GMPs, regulations, and current industry trends.
  • Problem-solving/critical thinking skills to understand connections between different technical/quality system areas and recognize potential compliance issues.
  • BSc degree (or higher) in Biotechnology, Chemistry, Biology, or relevant discipline.
  • A Stamp 1G or a Stamp 4 visa, as candidates must possess either a Stamp 1G or a Stamp 4 visa to work in the pharmaceutical sector in Ireland.
Benefits:

To be considered for this role, you must have a strong track record of regulatory compliance and excellent problem-solving skills.

You will have the opportunity to work in a state-of-the-art facility and contribute to the quality assurance team's efforts in maintaining high standards of manufacturing and testing.

Others:

Please note that possession of a Stamp 1G or a Stamp 4 visa is mandatory for working in the pharmaceutical sector in Ireland.

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