£80000 - £85000 per annum
+44 (0)151 666 8956
about 1 year ago
My client is a multinational Pharmaceutical Manufacturing company. They are looking to recruit a QP / Qualified person with substantial Sterile Manufacturing site experience to join the business on a permanent basis.
Duties will include;
- Execute Qualified Person (QP) 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 should be complied with.
- Ensure that products are manufactured in accordance with GMP, site procedures and applicable regulatory requirements.
- Maintain 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.
- Undertake regular audits, self-inspections and spot checks.
- Undertake 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.
- Act as change agents by gaining support for and driving sustainable improvements to ways of work
- Proactively ensure continuous improvement of the QMS and that it is inspection ready and maintained in a state of control
- Proactively drive and react to system trending (e.g. deviations, complaints and environmental management) to ensure ongoing quality performance and improvements.
- Establish and maintain effective communication with clients to match internal and external client expectations
- Backup for other QP’s on site and Deputise for the sites Quality Director
- Minimum Degree in Chemistry, Pharmacy or Microbiology
- Minimum experience of acting and executing ‘Qualified Person’ responsibilities and duties as defined in 2001/83/EC and 2001/82/EC (as amended)
- Substantial experience working in a pharmaceutical quality function within a sterile manufacturing site.
- 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.
- Excellent scientific and technical knowledge
- Pre-requisite for this job is that the candidate is not on the “FDA DEBARMENT LIST”
Scantec Personnel Limited is acting as an employment business and an employment agency. For contract or interim roles (and unless otherwise stated), all pay rates stated are on a Limited Company basis.
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