Hobson Prior are currently looking for a Senior QA Specialist to join a biotechnology company based in Ireland on a contract basis. Our client focuses on neurology and immunology disorders and purely aim to change the lives of people suffering from severe diseases. This role is accountable for all medical device product release activities to make sure that products are manufactured and released in accordance with regulatory requirements.
- Involvement with the final release of medical device products from contract manufacturing organizations for E.U. and international markets including manufacturing, inspection, packaging and labelling batch records to ensure compliance.
- Creation of associated product release certificates, archiving of electronic and hard copy batch documentation.
- Accountable for making sure all appropriate CMO batch related documents are available, and all documentation issues including queries, deviations, change controls, out of specification investigations and CAPAs are closed to enable release of products efficiently.
- Liaising with cross functional teams and CMOs to align on product release timelines and resolve batch record issues.
- Oversee activities relating to contract manufacturers including creation and updating of quality agreements, processing new supplier requests and supplier change notifications.
- Assist with medical device complaint investigations including batch record reviews.
- Support setup of medical device release processes for new product launches, including managing associated change control actions and subject matter expert for medical device product release processes.
- Develop, maintain and report quality system metrics relating to medical device product release activities as required.
- Make sure that the documentation systems to support Device Quality are maintained.
- Prepare and/or update standard operating procedures, device master records and product specifications.
- Meticulous eye to detail and strong decision-making skills.
- Strong time management skills and the ability to prioritise activities.
- Excellent verbal and written skills.
- Admirable analytical and problem-solving skills.
- Degree or equivalent in Science, Engineering or an equivalent technical discipline is required.
- Minimum of 3 years’ experience in a Quality role working with medical device/in-vitro diagnostics/ combination products in a regulated healthcare industry.
- In-depth knowledge of E.U., U.S. and international medical device regulations and standards including ISO 13485, ISO 14971, E.U. Medical Device Directive (MDD) and relevant CFRs is required.
- Experience with deviations, non-conformances, out of specification investigations and CAPA.
- Prior experience with SAP, Trackwise or similar systems.
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.