Qualified Person

Recruiter
Real Staffing
Location
Staffordshire
Posted
15 Sep 2017
Closes
21 Sep 2017
Sector
General
Contract Type
Full Time
QUALIFIED PERSON - £70,000 - STAFFORDSHIRE I am currently working with a leading Pharmaceutical company based in Staffordshire who are actively looking for an experienced QP to join their expanding site. Responsibilities: Lead the development and maintenance of the Company's Quality System to meet the requirements of the relevant regulatory authorities for medical devices and pharmaceutical products (e.g. MHRA, Notified Bodies and ISO Standards, as applicable) and all other applicable quality and regulatory standards. Liaise with RA in compiling application for regulatory approval. Actively participate in preparation and approval of site documentation including policies, procedures and associated reports, as well as annual reviews when required. Act as lead auditor for the GMP audit/inspection program for the facility, systems (including automation systems) and operations in supported areas. Support the external suppliers audit schedule Play a leading role in quality system audits of the site by regulatory bodies or customers. Develop a culture of continual improvements within the Quality Management System, ensuring compliance to all relevant Quality Standards and Regulatory requirements. Leading an effective CAPA system, including investigations, root cause analysis, risk assessments and implementation of change controls and CAPAs as appropriate. Requirements: Qualified person (QP) Lead auditor qualification Degree in life sciences or other related faculty Proven experience of managing multiple work streams and being able to prioritise and self-manage. If you would like to learn more about this position then please contact Sarah Irvine on 0207 758 7311 or reply directly to this advert. We also offer shopping vouchers for any successful referrals so if you know of someone who may be suitable then please feel free to get in touch. Sthree UK is acting as an Employment Agency in relation to this vacancy.