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Quality Assurance Officer

South West London   •  £24000 - £25000 per annum  •  Permanent, Full time

Achieva currently have an opportunity for a Regulatory Affairs Officer to join a medium-sized Pharmaceutical company.

The role: 
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.

Skills and Qualifications: 

? Degree level in a Life Science subject or equivalent in relevant experience.
? 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 with regard to 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 - Volume 4 - Good Manufacturing Practice (GMP) guidelines
? Relevant knowledge and experience related to the distribution of medicinal products
? Direct experience in conducting a broad range of audits.
? Effective time management.
? Mathematics
? IT skills
? Skills in English language and writing

For more information please contact fhatib@achieva.co.uk or 01727 817600.

  • Agency: Achieva Group Limited
  • Contact: Fandi Hatib
  • Phone: +44 (0)1727 811 634
  • Reference: 32344
  • Updated: 8th October 2021
  • Expires: 5th November 2021

Achieva Group Limited

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