Quality Systems Officer
Posted on Sep 26, 2019 by Real Staffing Group
Key Duties and Responsibilities:
- Ensuring that we continue to operate 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.
- Preparation and updating of company SOPs.
- Ensuring that internal and external QA documentation is prepared and completed correctly as per the regulations and company SOPs.
- 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.
- Generation and reporting of Quality metrics.
- Logging product complaints, following up with suppliers on investigations in conjunction with the Manufacturing Specialist and close investigations within agreed timeframes.
- Updating and maintenance of Quality documents eg 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 internal audits, carrying out of internal audits and ensuring that the review, monitoring, reporting of the inspections are completed. Ensuring audit action items are closed within agreed timeframe.
- 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.
- Providing administrative and/or technical support with respect to preparation, assembly, filing and distribution of information relating to product registrations, compliance and pharmacovigilance.
- Assisting with the maintenance the product technical files.
- Preparing regular Quality Management System updates.
- Ensuring that training plans are implemented and training records are maintained.
- Performing of other tasks as will be required from time to time.
The ideal candidate will have a background in a scientific discipline or pharmaceutical industry.
Skills & Competences:
The successful candidate will possess the following:
- 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.
- Strong organisational skills, ability to prioritise work and systematic approach to tasks.
- Highly motivated self-driven and "can-do-attitude".
- Enjoy and thrive in a fast-paced environment.
- As we work with stakeholders within and outside the company, the ideal candidate will demonstrate excellent interpersonal, communication and presentation skills, strong analytical and problem-solving skills.
- Applicants must also possess the ability to work well both on their own initiative and also within a team environment.
- High level of proficiency in Microsoft Office in particular, Word and Excel.
- Proficiency in speaking, comprehending, reading and writing English is required.
If you are interested in applying for this role please do so directly through this add or alternatively contact Adam Murtagh in Real Staffing.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales