Quality Systems Officer
- Ensure continuation of operations in accordance with European GMP/GDP regulations for drug products, the Medical Device Directive and ISO regulations for medical devices, and any other relevant guidelines related to the business.
- Preparation and updating of company SOPs; ensuring that internal and external QA Documentation is completed correctly.
- Assisting with the preparation of Technical Agreements with all relevant suppliers.
- Controlling and maintaining the document archive and sample retention system.
- Maintaining systems relating to QA, including change control, deviations, CAPA, complaints, audits and vendor approval and logging any product complaints following supplier investigation in conjunction with Manufacturing Specialist.
- Generation and reporting of Quality metrics.
- Updating and maintenance of Quality documents e.g. product specifications.
- Maintaining the stability programme including scheduling, ensuring testing is completed, results are reported on time and any out of specification results investigated.
- Assisting with the preparation of the Quality Management Reviews and Product Quality Review.
- Assisting with the preparation of in-house training and external training.
- Perform QA checks on documentation prior to release of products for sale.
- Coordinating and executing internal audits, ensuring that the review, monitoring, reporting of the inspections are completed within an agreed time frame.
- Assisting with audits and checks on suppliers and ensuring the review, monitoring and reporting of the audits.
- Assisting with preparation for Health / Competent Authority and Notified Body inspections and prepare regulatory inspection responses.
- Facilitating inspections by Third Parties.
- 3rd level qualification in a science discipline.
- 3 to 5 years of experience in the pharmaceutical and/or medical device industries. Specific experience working in a quality systems or quality assurance role is a requirement for this position.
- User experience of electronic Quality Management Systems (previous experience of system administrator would be an advantage)
- Strong background in the application of ISO 13485 and GMP/GDP standards.
- Project Management knowledge and practical experience
- Previous experience in regulatory inspections, supplier audits and customer audits.
- Enjoy and thrive in a fast-paced environment.
- Excellent communication skills, with a solution and systematic based approach
*Please note - Stamp 4 Visa OR EU Passport is required for this role as sponsorship is not provided.*
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales