Our organization is seeking a skilled Quality Assurance Specialist to ensure the quality and compliance of medicinal products.
Key Responsibilities:
* Comply with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release.
* Verify that products are manufactured in accordance with relevant GMPs.
* Disposition bulk product as acceptable for release or reject based on information available relating to manufacture and testing of the product.
* Ensure patient safety based on information available relating to manufacture and testing of the batch.
Requirements:
* Third level qualification in a science discipline with 5 years' experience in the pharmaceutical industry.
* Hold a Master's degree in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status.
* Gain 5 years industrial experience in an FDA and EMEA approved pharmaceutical environment.
* Obtain 2 Years' experience in an aseptic processing environment, preferably within a quality function.