We are a leading Genetic Testing organisation seeking an experienced QA & RA SPECIALIST to join our team in Barcelona on a permanent, full time basis, with flexible working patterns available.
- Author or review Standard Operating Procedures within the company QMS. Liaising with appropriate stakeholders to progress updates and approvals in accordance with the company Quality Management System (QMS). This may include writing and reviewing QMS documents.
- Manage contractor quality related activities, ensuring compliance with the QMS and registration requirements.
- Perform complaint investigations, progressing all complaints to closure within stablished due dates, and providing support to Customer Service team in all customer enquiries.
- Support Non-conformance, CAPA and Risk Management processes. Log all quality investigations, product disposition, validation activities, quality complaints, OOS or other quality issues as required, liaising with internal subject matter experts as applicable.
- Managing QMS related software (eQMS, LIMS, ERP) validation and control plans, ensuring accuracy and completeness of all documentation and raw data. Ensuring that all phases of software system Life Cycle Management, including deployments and implementations, are adhered to.
- Support company software validation and control plans, authoring and/or reviewing software validation deliverables for GENinCode products.
- Work with internal SME and external subcontractor to ensure compliance with regulatory cybersecurity and data integrity requirements.
- Handle change control requests as assigned, initiating and routing changes for evaluation and/or approval, and monitoring progress of related action items.
- Participate and support Management review meetings, performing trend reviews and compilation of metrics (KPIs) as required.
- Support Post-market surveillance program, liaising with appropriate stakeholders, and compiling the annual Product Reports for GENinCode assigned products, including those manufactured by external contractors.
- Support Internal and External Audit program and participate as main auditor as assigned.
- Support Notified Body and Regulatory Authorities inspections.
- Deliver internal and external training on QMS as assigned.
- Work with the Development team to ensure smooth and timely introduction of new products.
- Work closely alongside RA and QA colleagues to ensure that actions are consistent with the Company’s overall regulatory strategy and quality policy / objective, and ensuring regulatory requirements, processes and procedures, such as post-market surveillance, and removals and corrections (recalls) are implemented, followed and met.
- Support the preparation of EU CE Mark technical documentation (and UK equivalent), US FDA submissions (including pre submissions, pre-market notifications, pre-market approvals, etc.) and other regulatory submissions and manage the submissions / review process with the respective regulatory authorities through to completion (approval, clearance, etc.) in the EU as assigned.
- Ensure legislative/regulatory changes are communicated and embedded in the QMS and participate and deliver QMS training as assigned.
- Attend meetings and participate in new projects as Quality representative, as designated by line manager.
- Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends, providing support on customer enquiries and/or complaints management.
- Other duties (within your abilities) as and when required by the Management team and Clinical Scientists
- As a QA & RA Specialist you MUST degree or equivalent in Science.
- Strong background in FDA, ISO and EU regulations for In-Vitro Diagnostics Devices, Medical Devices, and healthcare; in particular FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 11.
- Expertise in Computer Systems Validation in In-Vitro Diagnostics Medical Device, Medical Device under IEC 62304 and IEC 82304.
- Expertise in validation of enterprise-wide quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.
- Good knowledge of risk management tools (ISO 14971).
- Good knowledge of Medical laboratories Requirements (ISO 15189)
- Understanding of current inspectional practices of Notified Bodies and other Regulatory Agencies including previous interface with such bodies during regulatory assessments or inspections.
- Ability to apply current inspectional techniques to ensure a comprehensive documentation package is created and maintained.
- Minimum 5 years of experience in QA, QS or RA in-Vitro Diagnostics Medical Devices or Healthcare industry.
- Good interpersonal and communication skills. Personable and able to communicate with staff of all levels. Able to work cross-functionally.
- Work effectively, independently and under supervision, being able to adapt to fast pace rapidly changing environment. Flexible approach to work and the tasks to be undertaken.
- Fluent in English (oral and written)_main language used within the company for internal communications and QMS documents.
- Fluent in Spanish (oral and written)_main language to be used to communicate with AEMPS
- Other EU spoken languages desirable.
- Essential Microsoft Office package knowledge.
- Neg salary subject to experience
- Full Time Permanent Role / flexible working patterns available. Possibility of working from home.
- Occasional travel (10% or less)
- Excellent company benefits
- Leading Genetic testing organisation
To apply for this post please email email@example.com
PLEASE NOTE – Only Shortlisted applicants will be contacted.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin or disability.