Hobson Prior are currently seeking a Qualified Person for a global contract development and manufacturing organisation, who are focused on allowing their customers to make the world healthier, safer and cleaner.
- Implement Qualified Person responsibilities, duties, batch certification and disposition as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU and Eudralex Volume 4, Annex 16. If the product is to be released to the US market, all appropriate cGMP's requirements as defined is US. “CFRs” and other relevant regulations.
- You will make sure that products are manufactured in accordance with GMP, site procedures and applicable regulatory requirements.
- Uphold a thorough and up to date understanding of international regulatory guidance, corporate and client requirements pertinent to the site, and to ensure that all work within the site complies with these and with site procedures.
- Take actions necessary to maintain and extend their technical and professional competence and to ensure that they have a thorough understanding of any new product or process prior to conducting any QP batch certification and disposition.
- Take on and support investigations, root cause analysis and review & approve Major/Critical deviation, Complaints and any change proposals with process/product impact.
- Undertake and support the QMR process.
- Undertake and support the implementation of Operation Excellence by encouraging peers and stakeholders to identify, lead and implement improvements.
- Take on regular audits, self-inspections and spot checks.
- Represent as change agents by gaining support for and driving sustainable improvements to ways of work.
- Capable of working to deadlines and prioritize multiple tasks.
- Excellent communication skills both written and verbal to internal and external stakeholders.
- Flexibility to meet changing needs and priorities of the business.
- Well organised with logical and methodical approach to work.
- Enable to guide cross-functional teams of professionals.
- Minimum Degree in Chemistry, Pharmacy or Microbiology.
- A minimum of 3 years’ experience acting and executing ‘Qualified Person’ responsibilities and duties as defined in 2001/83/EC and 2001/82/EC.
- A vast experience working in a pharmaceutical quality function within a sterile manufacturing site, experience with Cephalosporins/Penicillin is preferable.
- Up to date knowledge of the principles and guidelines for GMP as set out in: UK “Orange Guide”, EU “Eudralex Volume 4”, U.S. “CFRs” and other relevant regulations.
- Strong scientific and technical knowledge.
- Essential that the candidate is not on the FDA DEBARMENT LIST.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.