Published16 May 2023
LocationWigston, England, United Kingdom
An opportunity has arisen to join the Quality Assurance team, reporting to the Principal Quality Officer –Quality Systems. The purpose of this role is to support the implementation of additional modules to our existing electronic Quality Management System – Q-Pulse. The successful candidate will work closely with the QA team to drive implementation of new and updated Q-Pulse processes whilst ensuring that the system continues to maintain compliance with cGMP, ISO:13485 and internal procedures. In addition, this role will provide support and administration for the Q-Pulse system and act as a Subject Matter Expert (SME) in these areas. Based in Martin House, the role will involve:
• Assisting the Principal Quality Officer with the administration of Q-Pulse.
• Validation of new modules on Q-Pulse and revalidation of existing modules where required.
• Updating and generating SOPs for the use of Q-Pulse.
• Undertaking or coordinating training sessions, including but not limited to: Initial and Periodic QPulse, Pharmacovigilance and GMP training.
• Review of documentation including Standard Operating Procedures.
• Supporting departments in the review, update and issue of key documentation in order to sustain good documentation practice.
• Review of Q-Pulse records including complaints, change controls and deviations.
• Interrogation of Q-Pulse for monthly and quarterly KPIs.
• Client liaison for Quality matters, including assistance with customer audits.
The ideal candidate will have the following experience and abilities:
• A Science-based honours degree.
• Demonstrable experience with designing, implementing or validating electronic Quality Management systems or modules.
• A strong background in Quality Assurance with a minimum of three years’ work experience within the Pharmaceutical and/or Medical Device industries.
• Working knowledge of The Medicines Regulations 2012 as amended, ‘The Rules Governing Medicinal Products in the European union (Eudralex) – Volume 4’ and US Code of Federal Regulations, 21CFR.
• Experience of working with aseptic products and investigational medicinal products (IMP) and/or commercially marketed products would be an advantage
• Will have demonstrated the ability to drive effective change and continuous improvement during their career to date.
If you are interested in applying for this position, please send your CV with a covering letter to: Millie Marks, Nova Laboratories Ltd., Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL or alternatively via email at firstname.lastname@example.org