Our client is one of the world's leading providers of injectable drugs and infusion technologies that have been hugely successful in improving patient and caregiver safety, cost management, caregiver efficiency and clinical outcomes.
They are currently looking for a new Quality Assurance Auditor to join on a 12 month fixed term contract- likely to lead to permanent work for the right individual.
This is a fantastic opportunity as a Quality Assurance Auditor for GMDP pharmaceutical and medical device activities in the EMEA region, to provide effective and compliant management of vendors to assure compliance to policies and procedures, adhering to local / global regulatory requirements.
This is a key role, demanding an autonomous approach to your work within the quality assurance team requiring minimal direct supervision; meeting and reporting to line management fortnightly basis.
Job Description for the Quality Assurance Auditor
- Lead audits and follow up with vendors and service providers including Ingredients providers; Warehouse Storage and Distribution sites. The role involves up to 50% travel across EMEA (mostly within the EU/EEA).
- Participate in Vendor Assurance processes, negotiation and management of Technical Agreements, oversight of suppliers and service providers, liaison with the global supplier management, support of supply chain mapping and generation of QP Declarations.
- Support with internal audits.
- Support with critical quality or safety events and recalls.
- Provide support to regional and country offices and affiliates for management of Health Authority GMDP Inspections
- Development - to participate and lead audit of manufacturing sites of medicinal products (including manufactures of sterile injectable products).
- Support of EMEA Quality Management Systems including Deviations, change controls, quality management reviews and product quality reviews.
Essential Experience required for the Quality Assurance Auditor
- Bachelor's Degree: Science or Engineering related.
- Knowledge of EU GMP - EU regulations 2001/83/EC, 2003/94/EC is essential and ISO 13485 / ISO9001 preferred.
- Trained GMP/GDP auditor, with experience of performing, reporting and following up on GMP audits.
- Experience in the manufacturing, quality assurance and quality control of medicinal products, including an in-depth knowledge of Quality Management systems is essential.
Advantageous experience required for the Quality Assurance Auditor
- IRCA accredited advantageous.
- (Experience in steriles and/or biologics would be an advantage).
- Experience of quality risk management would be an advantage.
- Excellent communication skills, able to utilize a variety of media to ensure that information is shared with clarity, in an appropriate form, in a timely manner.
Sound like you? Apply NOW! Don't miss out on this exciting opportunity as a Quality Assurance Auditor Today!
If you have any further queries regarding this role please call James Powell 0203 8000509
Projectus Consulting are a leading Medical Device Recruitment Consultancy. We're a niche business who provide a highly specialist service to both employers and candidates in the Medical Technology Sector.
We are dedicated to finding the right opportunity for you.