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QA Expert

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Ipsen

Nov 11

  • Job
    Full-time
    Senior Level
  • Healthcare
  • Wrexham
  • Quick Apply

AI generated summary

  • You must have expert cGMP/QRM knowledge, strong organizational skills, effective communication, evaluation and root cause analysis abilities, and be ready to support the QA Operations Process Leader.
  • You will ensure GMP compliance, lead process improvements, report compliance issues, engage in QA discussions, coach others, and influence leadership decisions with your expertise.

Requirements

  • 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
  • Depute for the QA Operations Process Leader when required
  • Be a point of contact for Quality events and escalations accordingly

Responsibilities

  • 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.

FAQs

What is the primary focus of the QA Expert role at Ipsen?

The primary focus of the QA Expert role is to provide expert-level quality support to the Ipsen business, particularly at the Ipsen Wrexham site, across manufacturing activities, biologics development, engineering, qualification, validation activities, and the Pharmaceutical Quality System.

What qualifications are required for the QA Expert position?

The QA Expert position requires expert knowledge of cGMP (current Good Manufacturing Practices) and QRM (Quality Risk Management) relating to pharmaceutical manufacturing.

What key skills are desirable for this role?

Desirable skills include being highly organized with good prioritization, time and risk management techniques, excellent evaluation and root cause analysis skills, and the ability to communicate effectively and work collaboratively in a cross-functional team.

Will the QA Expert have leadership responsibilities?

Yes, the QA Expert will lead conversations, contribute to key discussions associated with Quality Assurance, and may deputize for the QA Operations Process Leader when required.

What kind of work environment can the QA Expert expect at Ipsen?

The QA Expert can expect a fantastic culture and working environment, with a commitment to diversity and inclusion, as well as sustainability, all within a rapidly growing organization.

Is there an opportunity for professional development in this role?

Yes, there will be opportunities to provide coaching and learning opportunities to others and to actively lead improvements to practices and procedures.

What types of products will the QA Expert be involved with?

The QA Expert will be involved with the production of drug substance, including both commercial and clinical drug substance, as well as engineering, qualification, and validation activities associated with these products.

How does Ipsen demonstrate its commitment to diversity and inclusion?

Ipsen has a huge commitment to diversity and inclusion, with nearly 50% of their top 160 leaders being women, and they have received recognition as a 'Best Workplace for Women' in 2023.

What benefits does Ipsen offer to its employees?

Ipsen offers competitive salaries and an enhanced benefits package, which includes an annual bonus, a generous pension scheme, wellness allowance, and more.

What is the significance of the New Drug Product Facility investment at Ipsen's Wrexham site?

The investment in the New Drug Product Facility is aimed at increasing the scale and capability of the Wrexham site, ultimately enhancing the products developed for customers and supporting the company’s growth.

Manufacturing & Electronics
Industry
5001-10,000
Employees

Mission & Purpose

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in 88 countries