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