Achieva currently have an opportunity for a Regulatory Affairs Officer to join a medium-sized Pharmaceutical company.
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.
? IT skills
? Skills in English language and writing
For more information please contact firstname.lastname@example.org or 01727 817600.
- Agency: Achieva Group Limited
- Contact: Fandi Hatib
- Phone: +44 (0)1727 811 634
- Reference: 32344
Website: Achieva Group Limited
- Updated: 8th October 2021
- Expires: 5th November 2021