QA Officer

1 month ago

Wrexham, United Kingdom IPSEN Full time

**Title**:
QA Officer

**Company**:
Ipsen Biopharm Ltd

We are looking to recruit a **QA Officer** to join the team at our **Wrexham, North Wales** manufacturing site. The role reports to the QA Process Leader within the QA Operations team.
- Sound knowledge of cGMP and QRM relating to aseptic manufacturing
- Organised, with a good sense of prioritisation, time, and risk management techniques
- Ability to communicate and facilitate the operation of systems within Quality
- Logical, process driven thinker able to communicate clearly and work collaboratively in a cross functional team

**Education / Certifications**:
Ideal: BSc in a science discipline.

education/training.

**Experience**:
Ideal: 3+ years pharmaceutical experience in sterile manufacturing of which more than 1 year in

Quality Assurance

Minimum: 1+ year in pharmaceutical manufacturing in a Quality role

**Languages**:
English

The role of QA Officer will be responsible for reviewing and approving batch documentation to support the QPs in certification of site manufactured batches and release in accordance with EU regulatory requirements. As well as to provide Quality Oversight across manufacturing streams utilising knowledge of cGMP regulatory guidelines, and industry standards.

The QA Officer will also participate in Quality Management Processes: Unplanned Events, Complaints, Corrective/Preventive Actions (CAPA), Change Control, Product Recall, Blue Mountain, SAP and other site systems as required to identify and support improvements in site practices.

Finally, to support routine operational activities and continuous improvements associated with site manufacturing activities.

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