Job Title:
Quality Assurance Specialist
Job Description:
We are seeking a highly skilled and experienced professional to oversee the quality and compliance of commercial and clinical products in accordance with EU regulations and Good Manufacturing Practice (GMP) requirements.
The ideal candidate will be responsible for ensuring batch release of commercial and clinical products in accordance with regulatory requirements, providing technical expertise on QA and compliance topics/issues relating to manufacturing and product supply, and monitoring company operations to ensure compliance with site licenses and GMP.
Key Responsibilities:
* Ensure batch release of commercial and clinical products in accordance with regulatory requirements
* Provide technical expertise on QA and compliance topics/issues relating to manufacturing and product supply
* Routinely monitor company operations to ensure compliance with site licenses and GMP
Requirements:
* QP Qualification with at least 5 years of Quality experience in an EU licensed facility
* Qualified Person status achieved with min 3-5 years of relevant work experience acting as Qualified Person named on a Manufacturing and Importation Authorisation (MIA/ IMP MIA)
* Aseptic / Sterile Drug Product manufacturing experience desirable
* Experience with IMP's (Investigational Medicinal Products) desirable
We offer a competitive salary and benefits package. If you are a motivated and experienced professional looking for a new challenge, please apply now.