Job Description
Join a globally recognized company specializing in the manufacturing of animal health products, with a specific focus on biologics.
Committed to advancing animal welfare through the development and production of high-quality veterinary medicines, their extensive facilities and dedicated team ensure that production meet the highest standards of safety, efficacy, and compliance.
We are now looking for a Qualified Person to join them as part of this exciting journey!
As a Qualified Person, you will play a pivotal role in ensuring the quality and compliance of the biologics manufacturing processes. Your expertise will be instrumental in certifying the release of products to market, maintaining adherence to regulatory requirements, and upholding their commitment to excellence in animal healthcare.
Responsibilities:
* Perform Qualified Person duties as mandated by UK and EU GMP legislation and the Qualified Person Code of Practice.
* Ensure thorough checks and tests are conducted to guarantee each batch complies with UK/EU GMP and Animal Health Quality standards.
* Release antigens and vaccines produced on the site in a timely manner.
* Maintain Continuing Professional Development as required by the QP Code of Practice.
* Stay updated with legislative changes and maintain product/process knowledge.
* Support regulatory and customer inspections as a Subject Matter Expert.
* Assist the site Quality Manager with quality issues, projects, and initiatives.
* Investigate and resolve quality issues such as deviations, CAPA, and change control.
* Support supplier qualification activities and conduct internal and external supplier audits.
* Contribute to key site projects and provide quality review and approval for critical projects.
* Mentor and develop employees' quality skills and support continuous improvement efforts.
* Participate in Quality Record Review and Qualified Persons training programs, when applicable.
* Facilitate cross-functional development and training related to Quality documentation review, particularly Batch Record documentation.
About You:
* Scientific degree in life science, pharmacy, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology.
* Preferably EU Qualified Person or eligible for nomination as per EU Directive 2001/82/EC.
* Extensive experience in veterinary/human medicines production within a Quality Assurance environment.
* Proficient in scientific principles, including physical-chemical, microbiological, and immunological assays, and European Pharmacopoeia standards.
* Excellent understanding of EU GMP and Quality Assurance requirements.
* Demonstrated leadership, innovative thinking, and adaptability to changing environments.
* Strong IT skills, including proficiency in MS Office, TrackWise, and SAP.
If you're interested in the above role then please click apply or get in touch
with to discuss further.
Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.
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