Job Description
Senior Quality Assurance Officer
Hybrid – 2/3-day office home.
Location –London
Working Hours – 9 to 5.30 or 8.30 to 5pm. Mon – Fri
Salary – 37, 000 – 41,500 per Annum
To conduct, coordinate and support quality aspects of the business operation, ensuring quality compliance throughout the business with focus on WDA, MIA and GMP and GDP activities
Required
- Degree level in a Life Science subject or equivalent in relevant experience ,BSc Pharmaceutical Studies beneficial.
- Over 3-5 years’ experience within the pharmaceutical and medical devices industry.
- Proven Quality Assurance experience in the pharmaceutical, biotechnology, or CMO industry, with a solid foundation in QA principles.
- Relevant knowledge and experience related to the distribution and/or manufacturing of medicinal products.
- Strong analytical skills and keen attention to detail to identify and address potential quality issues.
- Proficient writing skills, using appropriate software tools to develop and edit documents, procedures, and reports, contributing to comprehensive documentation and compliance.
- Understand the role of the MHRA (and other competent authorities) in the licensing of medicines, including the risk-based inspection process, the role of the enforcement group, the Inspection Action Group (IAG) and resulting actions that can be taken due to non-compliance.
Good understanding and of GMP / GDP including :
Knowledge of Quality Management system within a pharmaceutical background.
UK regulations about the Wholesale Distribution activity including importation.
Knowledge of the Falsified Medicines Directive 201162EU
Knowledge of the role of the European Medicines Agency (EMA) and use of EUDRAGMDP.
Knowledge of EudraLex – Good Manufacturing Practice (GMP) guidelines.
Direct experience in conducting a broad range of audits.
- Good understanding of certification for products traded under the organisation Health WDAs and MIAs
- Ideally someone who has worked in a virtual pharma company previously and has rich experience, to work with contract organisations and manufacturers, and familiar with activities such as written, review and creation of technical quality agreements, and vendor performance review etc.
- High proficiency in office based/or similar programmes (i.e. : Microsoft Word, Excel, Power point, Outlook & Teams).
- Good inter-personal and communication skills to communicate complex information to others and be able to put across ideas in a clear and concise manner and present a well-structured case.
- Effective online communication, as well as face-to-face.
- Ability to work under pressure and to tight time deadlines with prioritisation of work.
- Excellent attention to detail.
- Effective time management.
- Self-motivated & highly target driven.
For further details, please contact Rudo Urayayi on +44(0)1727 817 616 or email a copy of your CV to rurayayi@achieva.co.uk
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