Job DescriptionQuality Assurance Assistant
£25,000 - £28,000
My client has a unique opportunity for a QA Assistant to join a team of 4 in the QA department where you can train and develop within a leading and growing Pharmaceutical business. They can even offer study support if this is something of interest.
- To provide quality and compliance support to EM Pharma’s Quality Management systems.
- To ensure EM Pharma product, processes and procedures comply with relevant legislation such as GMP, GDP, ISO 13485, ISO9001 and BRC requirements.
- To ensure EM Pharma fulfil its obligation as legal manufacture of medical devices and MHA holder for licenced medicines.
- To provide quality support to the Technical Manager and Quality Manager.
- To manage the implementation of the Quality Management Systems.
- To administer the quality complaints procedures.
- To conduct internal audits, and manage corrective actions plans.
- To maintain quality improvement plans.
- To maintain quality documentation logs.
- To manage SOP logs ensuring they are reviewed in line with agreed timings.
- To coordinate the yearly review of quality documents such as HACCP plan, Technical File reviews.
- To maintain QIR and non-conformance logs.
- To provide cover for other members within the quality department.
Skills and Knowledge Required:
- At least 1 years Quality experience within a in regulated environment.
- Good communication skills.
- Understanding of regulations supporting healthcare product development, ie GMP, GDP, Medical Device ISO 13485.
- Ability to challenge peers and senior management whilst maintaining overall co-operation and goodwill.
- Demonstrate attention to detail at all times.
- Ability to evaluate information and draw conclusions based on facts.
Please Apply ASAP for immediate consideration.