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We are actively recruiting for aQuality Assurance (QA) Officerto join our Client's dynamic QA Operations Team.
This permanent position is located at their Wrexham site in North Wales and will report directly to the QA Process Leader. The role involves working on a 24/7 shift basis.
Main Duties -
- 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
Main responsibilities -
- 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.
The successfulapplicantwill 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.
Our Client is 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
If this sounds like the role for you - Please call us NOW to discuss further!
Saske Ltd are acting as anemployment business/agencyin relation to this vacancy advert.
Saske Ltd acts as an employment business for the supply of temporary workers and as an employment agency for permanent recruitment introductions.
Please note that our job adverts are correct at time of publication, but some details and job responsibilities are subject to change.
This job advert may not be copied, imitated or used, in whole or part, by third-party websites, without prior consent from Saske Ltd.
NO Recruitment Fees or related costs are paid by workers for applying or accepting this role with Saske Ltd.
