Quality Assurance Manager

1 week ago

Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €80,000
Job Description

This is a 6-month contract role with a leading Biotech Consultancy firm. As a Quality Assurance Specialist, you will be responsible for evaluating and releasing products to ensure conformance to all applicable policies and governing regulations.

You will also review and approve change controls, manage routine and complex deviations and complaints, and conduct analytical change requests and support process modification change controls.

In addition, you will be responsible for stability program management, including reviewing stability reports and assembling Annual Product Reviews.

You will provide on-site guidance in the preparation of metrics, procedures, and guidelines, and track and monitor operational and quality performance of the EP/ExP.

  • Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations
  • Review and approve change controls
  • Manage routine and complex deviations and complaints and assist in the coordination of significant investigations
  • Conduct routine and solve complex analytical change requests and support process modification change controls
  • Stability Program management, including review of stability reports, and Annual Product Review assembly
  • Provide on-site guidance in the preparation of metrics, procedures, and guidelines
  • Track and monitor operational and quality performance of the EP/ExP and can work with supplier to develop Corrective and preventive action (CAPA) plans
  • Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration
  • Responsible for shipment under quarantine
  • Support routine process validation; review and approve validation reports/tech transfer
  • Prepare pre-PAI assessments, support document requests for regulatory filings and post approval changes

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