My client, a Pharmaceutical company based in South West London, are currently recruiting for a QA Officer to join my client on a permanent basis. You will ideally have 1-2 years of experience, but this role will also suit a recent graduate who has some relevant exposure.
Quality System Maintenance & Management
· To ensure that a quality management system is implemented and maintained and appropriate to the activities at the client inclusive of the EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C343/01) and EudraLex ? Volume 4 ? Good Manufacturing Practice (GMP) guidelines.
· To ensure that the clients Quality system supports good documentation practice and data integrity principles, and effective governance of all company SOPs.
· Maintenance for the awareness of new and revision to existing quality directives: (E.g. Falsified Medicines directive 201162EU, Directive 2003/94/EC and EudraLex ? Volume 4 ? Good Manufacturing Practice (GMP) guidelines.
· Ensure Quality Assurance (QA) business and regulatory requirements are met at all times by all 3rd party suppliers, service providers and customers and Operational activities are compliant with authorised activities and scope detailed in the clients MIA and WDA licences, in order to support the clients business continuity.
· Support the collation and review of supplier licences and certificates.
· Support that medicinal products are procured, held and distributed are as authorised by WDA (and MIA) of company, storage premises and customers.
Qualification and Experience Required:
· 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.
· Good understanding of certification for products traded under the clients 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 also familiar with activities such as written, review and creation of technical quality agreements, and vendor performance review etc.
· Familiar with computer systems validation.
· 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.
For further details, please contact Tim Barratt on 01727 817 626 or email firstname.lastname@example.org
- Agency: Achieva Group Limited
- Contact: Tim Barratt
- Phone: 01727811634
- Reference: BH-32344
Website: Achieva Group Limited
- Posted: 24th September 2021
- Expires: 22nd October 2021