Quality Assurance Expert in Wrexham

2 months ago

Wrexham, Wrexham, United Kingdom Ipsen Biopharm Ltd Full time

Ipsen is a growing and dynamic specialty-driven biopharmaceutical company focussed on innovation and specialty care.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make a difference. We attract and develop bold, agile and entrepreneurial individuals who take full ownership of their decisions, leaders drawn by a purpose to make a direct impact through their work in people's lives, all of which is underpinned by our Ipsen Way of Being.

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

This is a versatile role in that it supports;

  • Manufacturing activities: Production of drug substance - review and approval of all documentation associated with release of drug substance
  • Biologics Development: Production of clinical drug substance - review and approval of all documentation associated with the release of clinical drug substance.
  • Engineering, Qualification & Validation activities associated with all drug substance, including projects
  • The Pharmaceutical Quality System, including: above-site Corporate and Global quality activities (incl. Quality Systems) as required and auditing resource
  • The customer Quality interface

What will you be doing...

  • Provide expert quality input and offer solutions based on knowledge of GMP, QRM and relevant manufacturing processes across all core functions within the product lifecycle.
  • Identify and actively lead improvements to practices and procedures.
  • Perform assigned tasks, whilst at all times, adhering to current GMP requirement for sterile medicinal products.
  • Report compliance concerns to the QA Compliance team.
  • Lead conversation and contribute to key discussions associated with Quality Assurance
  • Be considered an SME within QA and provide coaching and learning opportunities where considered necessary.
  • Liaise with and provide influence at leadership level, offering an opinion based on expert knowledge

What are we looking for...

  • Expert knowledge of cGMP and QRM relating to pharmaceutical manufacturing
  • Highly organised, with a good sense of prioritisation, time and risk management techniques
  • Logical, process driven thinker, able to communicate effectively and work collaboratively in a cross-functional team
  • Excellent evaluation and root cause analysis skills
  • Deputise for the QA Operations Process Leader when required
  • Be a point of contact for Quality events and escalations accordingly

Why Ipsen...

  • We are a business that is experiencing exponential growth and transformation, therefore presenting a wide range of opportunities and challenges
  • Major £multi-million investment in a New Drug Product Facility to increase the scale and capability of our Wrexham site, ultimately enhancing the products we develop for our customers
  • A fantastic culture and working environment with many long-serving employees
  • Huge commitment to Diversity & Inclusion - almost 50% of our top 160 leaders are women
  • A genuine focus on the environment and sustainability – our Wrexham site is powered by 100% renewable electricity
  • Competitive salaries and enhanced benefits package which includes annual bonus, generous pension scheme, wellness allowance and so much more.
  • Awarded 'Best Workplaces' and 'Best Workplaces for Wellbeing' status in the Large Organisations category, as well as 'Best Workplaces for Women' in 2023.

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