Hobson Prior are looking for a Quality Consultant to join a leading pharmaceutical company who specialise in immunology and neurology and aim to deliver pioneering products to enable people suffering from serious illnesses live a better life.
- You will deliver expert advice, support and management for technical operational QA and general QA matters for specific vendors, on behalf of the company, in design/development of medical devices and combination products ensuring application of ISO and GMP requirements.
- Accountable to supervise Design & Development activities, from Inputs definition through Design Transfer.
- Evaluate and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc.
- Make sure risk assessments are performed at appropriate stages of development and for decision making on issues arising.
- Ensure deliverables are issued in accordance with the D&D plan.
- Supervise inspection plans at CMO and the company.
- Provide expert support to internal partners to assure systems are in place to manage novel new drug introducer technologies.
- Facilitate investigations and resolution of issues relating to deviation and change management.
- Review and approve deviations during D&D activities Lead/review critical investigations
- Track CAPA events and closure.
- Be proactive, confident and enthusiastic during the interaction with colleagues during team work and take the initiative to promote and share/implement best practices.
- You will have good interpersonal, verbal, and written communication skills and be capable to present information at interdepartmental and external meetings.
- Root cause analysis and risk management/assessment skills would be admirable.
- Practical experience in ISO13485, ISO14971, MDD/MDR and 21CFRpart 820 with main focus on Design Control.
- Either experience with 21CFR part 4 OR Medical Mobile Apps regulation.
- A minimum of 5 years working in the pharmaceutical/biologics/medical device industry in a quality management position.
- Practical understanding of ISO13485:2016, MDR, ISO14971 and 21CFR820 and part 4 requirements.
- Should have a US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques.
- Operational GMP experience or clinical activities experience would be a distinct advantage.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.