Senior Quality Assurance Officer
Onyx Scientific are looking for a Senior Quality Assurance Officer to join our fantastic QA team.
At Onyx Scientific, we are a trusted partner to a cross section of academic, biotech and pharmaceutical clients across the world, providing cutting-edge services from discovery through to commercial manufacture. As a fast-growing Contract Development and Manufacturing Organisation (CDMO), we are committed to scientific excellence, innovation, and delivering solutions that make a real difference to patients’ lives.
You will preferably (but not essentially) have a degree which is analytical chemistry or chemistry based and have experience in most modern analytical techniques such as HPLC, GC, FT-IR, LC-MS and wet chemistry techniques.
There are rewarding opportunities to be involved in organisation and planning for the department and to train and supervise members of the QA team.
The ideal candidate will be self-motivated and able to work without supervision. Excellent interpersonal skills, both verbal and written, are essential for working with colleagues.
Working within the GMP and safety guidelines set by the company, you 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.
Key Responsibilities:
- QA reviews of batch documentation (batch records, analytical reports/ raw data) and final
reports - Perform QA review and approval of GMP stability studies
- Perform the QA review and release of key raw materials and intermediates
- Review and approve change controls, non-conformances, SOP’s and other controlled
procedures - Perform internal audits and co-ordinate the timely closure of all audit actions
- Prepare or support the preparation of and maintenance of technical/quality agreements
- Assist in the annual GMP training
- Assist in the preparation and dispatch of customer QA package on completion of project
- Ensure procedures are followed at all times and new issues of Standard Operating Procedures
are signed off promptly - Demonstrate good safety awareness as described in the Onyx Safety Manual
Key Skills and Qualities:
- A degree in chemistry or a related field would be an advantage
- Good understanding of cGMP, ICH, Eudralex Volume 4 Part II
- 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
- The role requires meticulous attention to detail and accuracy and for all work to be conducted strictly in accordance with company Policies and Procedures and Standard Operating Procedures.
- Follow all Health, Safety and Environmental requirements that are defined on work instructions or communicated in training.
- Superior communication within the department, company and occasionally with clients.
- Able to demonstrate excellent problem-solving skills and can identify and resolve potential issues
- A flexible approach to working additional hours when required
- Work effectively as part of a team, showing resourcefulness and reliability
- Enthusiastic, flexible, conscientious and proactive in approach
- First-rate organisational, interpersonal, and time management skills
- Takes a positive approach to own training and development and that of others
What We Offer:
- A competitive salary, dependent upon skills and experience.
- Opportunities for career progression and ongoing professional development.
- The chance to work on diverse, high-impact client projects.
- A supportive, collaborative culture where your contributions are valued and recognised.
Benefits:
- Company events
- Cycle to work scheme
- Free on-site parking
- Health & wellbeing programme
- Life insurance
- Private medical insurance