Quality Assurance Officer

My client is a successful privately-owned, award-winning pharmaceutical company with a position open for a Quality Assurance Officer to join their team. They have state of the art facilities and this presents a fantastic opportunity for someone. The purpose of this role is to support the implementation of additional modules to the electronic Quality Management System. The successful candidate will drive implementation of new and updated processes whilst ensuring that the system continues to maintain compliance and internal procedures. In addition, this role will provide support and administration for the system and act as a Subject Matter Expert in these areas.

• 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 Q-Pulse, 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

• 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.
• 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