We are actively seeking a
Quality Assurance (QA) Officer
to join our dynamic QA Operations Team. This permanent position is located at our Wrexham site in North Wales and will report directly to the QA Process Leader.
The role involves working on a 24/7 shift basis. The Successful Applicant Will Have Sound Knowledge Of CGMP And QRM Relating To Aseptic Manufacturing And Will Be Organised With a Good Sense Of Prioritisation, Time And Risk Management Techniques Plus Able To Communicate And Facilitate The Operation Of Systems Within Quality. Against This We Are Also Looking For Candidates Who Have: Ideal: BSc in a science discipline. Minimum: A levels/equivalent, including a science subject or evidence of science-based 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. Ipsen is a rapidly growing global biopharmaceutical company focused on innovation and specialty care. Our aim is to make a sustainable difference by significantly improving patients’ health and quality of life through differentiated and innovative medicines in oncology, neurosciences and rare diseases. Requirements If successful, you will be responsible for the review and approval of batch documentation to support the QPs in certification of site manufactured batches and release in accordance with EU regulatory requirements, plus: 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. Main Duties & Responsibilities Your role will also include: 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. If you think this sounds like the right opportunity for you then don’t wait, apply today and become part of the team improving the lives of patients globally!
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Quality Assurance (QA) Officer
to join our dynamic QA Operations Team. This permanent position is located at our Wrexham site in North Wales and will report directly to the QA Process Leader.
The role involves working on a 24/7 shift basis. The Successful Applicant Will Have Sound Knowledge Of CGMP And QRM Relating To Aseptic Manufacturing And Will Be Organised With a Good Sense Of Prioritisation, Time And Risk Management Techniques Plus Able To Communicate And Facilitate The Operation Of Systems Within Quality. Against This We Are Also Looking For Candidates Who Have: Ideal: BSc in a science discipline. Minimum: A levels/equivalent, including a science subject or evidence of science-based 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. Ipsen is a rapidly growing global biopharmaceutical company focused on innovation and specialty care. Our aim is to make a sustainable difference by significantly improving patients’ health and quality of life through differentiated and innovative medicines in oncology, neurosciences and rare diseases. Requirements If successful, you will be responsible for the review and approval of batch documentation to support the QPs in certification of site manufactured batches and release in accordance with EU regulatory requirements, plus: 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. Main Duties & Responsibilities Your role will also include: 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. If you think this sounds like the right opportunity for you then don’t wait, apply today and become part of the team improving the lives of patients globally!
#J-18808-Ljbffr
