This is what you will do: 

The QA Manager for external quality operations supports the QA activities as required by Alexion External Quality in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. Intern for external quality performs’ all responsibilities in accordance with company policies, procedures, and regulations. 

You will be responsible for: 

• Quality Overight of Contract Manufacturing Organisations (CMOs) manufacturing Drug product on Alexions behalf. 

• Authoring, review and approval of QA-related procedures. 

• Review of batch documentation. 

• Tracking of quality management system activities including deviations, CAPAs and change controls. 

• Perform all job functions in compliance with cGMPs and maintain accurate and legible records. 

• Where required, maintain external quality metrics/key performance indicators ensuring site visibility and trending to support continuous improvement activities. 

• Documentation review of SOPs, master batch records, policies, standards, validation protocols and reports as required. 

• Other activities, as required to support the Alexion External Quality team and stakeholders. 

You will need to have: 

• This position requires the individual to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessary.  

• The person in this position will receive supervisory direction on all routine and non-routine activities. Routine activities will be unsupervised as training and competency develops. The person in this position must have good organizational skills and the ability to lead projects/ engage with cross functional stakeholders.  

• The position requires the individual to work collaboratively with colleagues, peers and managers. 

• A good understanding of the concepts and systems applied to cGMP operations is expected.  

• Proficient in the use of approved AI technologies to support analysis, risk assessment, and operational efficiency. Able to critically review AI-generated outputs, maintain data integrity, and ensure compliance with GxP and regulatory expectations. 

We would prefer for you to have: 

• B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry , Microbiology or Pharmacy 

• +5 years Quality experience, preferably experience working with CMO’s. 

Date Posted

Closing Date