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QA Officer-1

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Ipsen

1mo ago

  • Job
    Full-time
    Junior & Mid Level
  • Wrexham
  • Quick Apply

AI generated summary

  • You should have a BSc in science (ideally) or A levels in a science subject, with 1+ years in a Quality role, preferably 3+ years in sterile pharmaceutical manufacturing.
  • You will ensure GMP compliance, manage quality processes, review batch documentation, support operational improvements, and address compliance concerns while collaborating with site teams.

Requirements

  • Ideal: BSc in a science discipline.
  • Minimum: A levels/equivalent, including a science subject or evidence of science-based education/training.
  • 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

Responsibilities

  • To provide Quality Oversight across manufacturing streams utilising knowledge of cGMP regulatory guidelines, and industry standards.
  • To 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.
  • To support routine operational activities and continuous improvements associated with site manufacturing activities.
  • Support improvements to optimise departmental performance (efficiency and compliance)
  • Support improvements in site processing practices.
  • Perform assigned tasks whilst always adhering to current GMP requirements.
  • Report any compliance concerns to your line-manager.
  • Perform Quality review of all batch documentation in all site manufacturing facilities to ensure compliance to regulatory requirements and business lead times.
  • Provide general input/solutions based on knowledge of GMP, QRM and an understanding of batch processing.
  • Provide Quality input for general non-conformances, out of specifications, change control and CAPA in line with current Quality Compliance procedures. Escalate complex and/or critical activities to next level.

FAQs

What is the location of the QA Officer-1 position?

The QA Officer-1 position is located at our Wrexham site in North Wales.

What qualifications are needed for this role?

The ideal candidate should have a BSc in a science discipline, while the minimum requirement is A levels/equivalent, including a science subject or evidence of science-based education/training.

How much experience is required for the QA Officer-1 position?

The ideal candidate should have 3+ years of pharmaceutical experience in sterile manufacturing, with more than 1 year in a Quality Assurance role. The minimum requirement is 1+ year in pharmaceutical manufacturing in a Quality role.

What hours will the QA Officer-1 be expected to work?

The QA Officer-1 role involves working on a 24/7 shift basis.

What will the QA Officer-1 be responsible for?

The QA Officer-1 will be responsible for the review and approval of batch documentation, providing quality oversight across manufacturing streams, participating in Quality Management Processes, and supporting routine operational activities and continuous improvements.

Are there opportunities for improvement in this role?

Yes, the QA Officer-1 is expected to support improvements to optimize departmental performance and site processing practices.

What regulatory knowledge is required for this position?

The successful applicant will need to have sound knowledge of cGMP (current Good Manufacturing Practice) and QRM (Quality Risk Management) relating to aseptic manufacturing.

How should compliance concerns be reported?

Any compliance concerns should be reported to your line manager.

Is experience in a specific sector required for this role?

Yes, experience in the pharmaceutical sector, specifically in sterile manufacturing and quality assurance, is required.

How does this role contribute to the company’s goals?

The QA Officer-1 plays a critical role in ensuring compliance with regulatory requirements, which directly impacts the company’s mission of improving patients’ health and quality of life through innovative medicines.

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Ipsen

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