Quality Assurance Officer GMP
You have the chance to join a well established business and develop your quality improvement skill set in a hands on role. This Quality Assurance Officer (GMP) position will involve you working on sites in the Derbyshire region and cross functionally in order to drive best practice.
You have the opportunity to join a market leading group supplying specialist products into leading retailers. As the Quality Assurance Officer (GMP) you will be instrumental in ensuring efficient, flexible and responsive processes. You will be supporting the QA Manager in compliance to GMP regulations ensuring that work is completed in a safe and efficient manner and meeting the agreed standards of quality, GDP, GMP and service levels of the company, clients and regulatory bodies.
As the Quality Assurance Officer (GMP) you will be instrumental in delivering against and maintaining the company's quality improvement strategy. You will be working closely with the senior management contingent to form a best practice working culture.
- To ensure that all accidents and near misses are reported immediately to the Health & Safety Manager
- To ensure that all QA department activity is performed in accordance with company procedures and client instructions
- To ensure that all QA activity is appropriately documented
- To support the business in maintaining compliance to GDP, GMP and ISO 9001 standards
- To work with the production team in order to implement GMP projects, including new activities and equipment
- Supporting regulatory inspections
- Hosting client audits and managing any resultant findings and associated corrective actions in accordance with client expectations
- Support the maintenance of Client and Vendor Technical Agreements
- Proactively maintaining knowledge of applicable regulations; conducting required gap analysis and implementation of actions in order to maintain compliance
- Performing internal and supplier audits in accordance with a defined schedule
- Ensuring documents are managed, approved and controlled
- Supporting the site change control process by ensuring that quality critical changes are adequately documented and assessed
- Ensuring that quality incidents, client / customer complaints and deviations are appropriately recorded, investigated (including RCA as necessary), corrective actions identified and communicated; responsible for approval of Corrective Action plans
- Responsible for completing the UK and client specific Product Quality Reviews
- To ensure that all QA department activity is performed in accordance with defined procedures and client instructions and where applicable appropriate records are maintained
- Ensuring that all direct reports are trained in GDP and GMP and all relevant procedures
- Generating and reporting quality metrics both internally and to clients
- Maintaining awareness of client requirements as specified in respective Technical Agreements
- Supporting and monitoring direct reports in the continuous development of their skills and ensuring all direct reports are sufficiently trained.
A Quality Assurance specialist with the following:
- Ideally educated to Degree level
- Experience working in a GMP environment
- Thorough knowledge of GMP and an understanding of GDP regulations
- Knowledge of the pharmaceuticals regulatory framework within the UK
- Strong communication skills
- Effective leadership/management skills
Circa £30,000 + Benefits