QA Lead

QA Lead

Ipsen Pharma

Wrexham, United Kingdom

Job Description:

The role of the QA Lead in the QA Ops department is to provide expert level quality support to the Ipsen business, primarily based at the Ipsen Wrexham site.

The QA Lead role focuses on GxP aspects of customer complaints, requiring expertise in:

• The Pharmaceutical Quality System, including Global Quality Activities, QSEB, and JAF meetings.
• Acting as an audit contact and subject matter expert during site inspections.
• Serving as the Site Quality interface for all Wrexham Commercial Products with Ipsen Global counterparts.

What you will be doing…

• Build internal and external working relationships to allow management of Complaint cases. Quality Com Ops, Joint Assessment Forum, Quality Safety Evaluation Board, Global Patient Safety Team, Medical Information Team, All Complaint Managers, MHRA, FDA.
• Communicate complaint data, trends and improvement activities within the local and global Ipsen community. Support the investigation into product complaints and the development of CAPA to reduce the risk of recurrence.
• Provide expert quality input/solutions based on knowledge of GMP, QRM and relevant manufacturing processes to Ipsen affiliates, partners, and regulatory agencies & Health Authorities.

What we are looking for…

• Bachelor's degree is the minimum requirement..
• Extensive experience in Pharmaceutical Quality.
• Prior work history of complaint management, quality compliance and of packing technology.
• Knowledge of Global Regulations in relation to Product Security.
• Capable of communicating effectively with internal and external partners, health authorities, and representing Ipsen at industry events.
• Able to provide training to cross functional teams on Complaints and product security topics.
• KPI management.

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United Kingdom      On-site      Quality Assurance      Ipsen Pharma