Expert in Pharmaceutical Release

2 weeks ago


Warm Springs, Georgia, United States Spectrum Solutions Full time
Job Title: Expert Person for the Final Release of Pharmaceuticals

As a Qualified Person at Spectrum Solutions, you will play a crucial role in ensuring compliance with pharmaceutical regulations for the areas of manufacturing, testing, and release of medicinal products before they are placed on the market.

Key Responsibilities:
  • Release medicinal products for ACA Pharma in accordance with Annex 16 of the EU GMP guidelines, ensuring familiarity with the product and the processes used for its manufacture and testing.
  • Evaluate and approve deviations, ensuring that medicinal product batches have been manufactured and tested properly and comply with all aspects of the authorization at the time of release and the respective SOPs.
  • Approve SOPs and other regulations and documents, including supplements related to release, and participate in monitoring and contributing to the development of the QMS.
  • Provide information to the competent authority as part of the obligation to cooperate in accordance with § 66 AMG, insofar as it concerns release and authorization.
  • Participate in the assessment of complaints and recalls, especially in cases of quality defects.
  • Ensure that the Product Quality Review is created and evaluated at appropriate intervals and that all quality-critical systems are validated.
  • Ensure that retention samples are taken and stored in accordance with the relevant regulations.

What We Offer:

A challenging and rewarding role in a dynamic environment, with opportunities for growth and development.



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