Overview
Onyx Scientific are looking for a Quality Assurance Officer to join our fantastic QA team.
The successful candidate will ideally have a degree which is analytical chemistry or chemistry based. They will have experience in most modern analytical techniques such as HPLC, GC, FT-IR, LC-MS and wet chemistry techniques.
The ideal candidate will be self-motivated and able to work with minimal supervision. Good interpersonal skills, both verbal and written, are essential for working with colleagues.
The successful candidate will be work within the GMP and safety guidelines set by the company. They will assist the Quality Assurance Manager in ensuring the company Quality Management System (QMS) is maintained and complies with the requirements of Good Manufacturing Practice (GMP) as described in the current EU and ICH guidelines. They will perform routine duties with full supervision.
They will have a basic understanding of the daily requirements of the department to aid in its efficient running. They will liaise with senior staff within QA and other departments where required.
Key Responsibilities
* Perform QA reviews of PRS/PAR/logbooks/stability studies
* Perform QA reviews of Reference standard packs
* Perform QA reviews of equipment qualification documents
* Basic understanding of ALCOA++, GDocP
* Perform visual inspection of equipment/area
* Issue of processing documentation
* Issue of logbooks, SOPs
* Perform generation of change controls and NCR’s
* Perform scanning/filing/logging activities (if required)
* Perform archival of documentation (if required)
* Perform review of analytical data on Openlab 2.7 under supervision
* Review of EM data under supervision
* Review of Temperature mapping data under supervision.
Key Skills and Qualities
* Basic understanding of cGMP, ICH, Eudralex Volume 4 Part II
* Able to demonstrate basic problem-solving skills and can identify potential issues
* Able to communicate appropriately and effectively with colleagues
* Good attention to detail
* Familiarity of analytical techniques (if appropriate), their applications, and roles within the company.
* Able to use initiative, multi-task and plan work effectively to meet strict deadlines
* A flexible approach to working additional hours when required
* Computer literate, familiar with Microsoft Word and Excel
* Work effectively as part of a team, showing resourcefulness and reliability
* Good organisational, interpersonal, and time management skills
* Enthusiastic, flexible, conscientious and proactive in approach
* Takes a positive approach to own training and development
* Willingness to learn
Benefits:
* Company events
* Cycle to work scheme
* Free parking
* Health & wellbeing programme
* Life insurance
* On-site parking
* Private medical insurance