Social network you want to login/join with:
Quality Assurance Officer, Sunderland, Tyne and Wear
Client: Onyx Scientific
Location: Sunderland, Tyne and Wear, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Views: 5
Posted: 26.06.2025
Expiry Date: 10.08.2025
Job Description:
Overview
Onyx Scientific is seeking a Quality Assurance Officer to join our QA team.
The ideal candidate will have a degree in analytical chemistry or a related field and experience with analytical techniques such as HPLC, GC, FT-IR, LC-MS, and wet chemistry.
They should be self-motivated, able to work independently, and possess good interpersonal skills, both verbal and written.
The candidate will work within GMP and safety guidelines, assisting the Quality Assurance Manager in maintaining the Quality Management System (QMS) in compliance with GMP standards as per EU and ICH guidelines. Routine duties will be performed under supervision.
Basic understanding of departmental operations is required, along with the ability to liaise with senior QA staff and other departments.
Key Responsibilities
* Perform QA reviews of PRS/PAR/logbooks/stability studies
* Review Reference standard packs and equipment qualification documents
* Understand ALCOA++, GDocP principles
* Conduct visual inspections of equipment and areas
* Issue processing documentation, logbooks, SOPs
* Generate change controls and NCRs
* Perform scanning, filing, logging, and archival activities as needed
* Review analytical data on Openlab 2.7 under supervision
* Review EM data and temperature mapping data under supervision
Key Skills and Qualities
* Understanding of cGMP, ICH, Eudralex Volume 4 Part II
* Basic problem-solving skills and issue identification
* Effective communication skills
* Familiarity with analytical techniques and their applications
* Ability to use initiative, multi-task, and meet deadlines
* Flexibility to work additional hours when required
* Proficiency in Microsoft Word and Excel
* Teamwork, resourcefulness, and reliability
* Organizational, interpersonal, and time management skills
* Enthusiastic, flexible, proactive, and committed to training and development
#J-18808-Ljbffr