Senior Biopharmaceutical Quality Professional

1 week ago

Dublin, Dublin City, Ireland beBeeManufacturing Full time €70,000 - €110,000
External Quality Assurance Specialist

A reputable pharmaceutical organization is seeking an experienced Quality Assurance Specialist – External Manufacturing to oversee the production and distribution of high-quality biopharmaceuticals. In this role, you will ensure that all products meet stringent regulatory requirements and industry standards.

Key Responsibilities:
  • Evaluate and/or release products, ensuring conformance to policies and regulations.
  • Review and approve change controls.
  • Manage deviations and complaints, coordinate investigations.
  • Support process validation, review validation reports, and assist with regulatory documentation.
  • Manage stability programs and review stability reports.
  • Provide guidance on metrics, procedures, and guidelines.
  • Monitor external partner performance and develop CAPA plans.
  • Maintain retention samples and support regulatory filings.
Requirements:
  • Experience in pharmaceutical quality systems and regulatory requirements.
  • Problem-solving skills and ability to work independently.
  • Strong communication skills in English.
  • Knowledge of external manufacturing management and supply chain.
Preferred Qualifications:
  • Experience with biologics/vaccines manufacturing, aseptic processes.
  • Qualification of manufacturing facilities/equipment.
  • Analytical method validation and quality risk management.
Education:

Bachelor's or Master's in Science, Engineering, or related field.

This is a 6-month contract role, providing an opportunity to gain experience in the pharmaceutical industry and contribute to the development of high-quality biopharmaceuticals.

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