Pre-clinical QA Specialist
We are currently looking for a Pre-clinical QA Specialist to join a Global Biopharmaceutical company in the Berkshire area on an initial 6-month contract basis. As the Pre-clinical QA Specialist you will be part of the Pre-clinical QA team and will contribute to the execution of the risk-based Pre-clinical QA audit programme.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Pre-clinical QA Specialist will be varied however the key duties and responsibilities are as follows:
1. You will work within the Pre-clinical QA team and will provide critical thinking and assist with a wide range of GLP and GCP Lab regulatory activities, in the form of various document reviews and audits
2. You will be provide guidance and support to Discovery Research in the understanding of the basic principles of Good Research Practice, by means of reviews of research reports and research agreements
3. You will provide guidance and support to Discovery Research with respect to HTA guidelines
4. You will act in an advisory role and pro-actively assist the research teams with the identification and development of quality improvements
To be successful in your application to this exciting opportunity as the Pre-clinical QA Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific Discipline
2. A proven QA professional with a well-rounded understanding of and understanding of the UK, EU and FDA regulations (GLP), as well as the UK/EMA GCP Laboratory Guidelines.
3. You will be able to demonstrate the necessary attributes and behaviours for working with research scientists when discussing quality matters, to develop a trusted working relationship
Key Words: Pre-clinical QA Specialist / QA / Quality Assurance / GLP / GCP / GRP / GxP / QMS / Quality Management System / Discovery Research / UK / EU / FDA / MHRA / Regulatory / CAPA / SOP / Deviation / Change Control / Audit / Pharmaceutical / Biopharmaceutical / Risk / Documentation Review / Stakeholders
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.