Our client, a leading pharmaceutical organisation, are looking to hire an experienced and well qualified GDP Quality Manager to join the business on the next phase of growth within their business.
The GDP Quality Manager will play a key role within the business, driving GDP compliance across the business in line with MHRA guidelines. You will interface with stakeholders at all levels within the business and be of key support to the senior leadership team on compliance related issues to help with driving a culture of quality across the organisation.
The key responsibilities for the GDP Quality Manager will involve the following:
- Provide QA input on GDP activities, ensure product procurement, storage and distributions are managed in accordance with GDP requirements.
- Provide advice to the business/senior management team on legislative developments, therefore must have strong personal knowledge of all the relevant GDP guidelines.
- Provide guidance and monitor quality issues related to cold chain, ambient products and GDP to resolution within the company.
- Raise and review documentation including change controls, deviations, CAPAs, validation documentation, SOPs and specifications relating to distribution activities.
- Maintain, review and updating of Standard Operating Procedures for Quality Assurance and Distribution related activities ensuring compliance with GDP regulations.
- Contribute to defining standard GDP quality KPIs and to review quality indicators with recommendation for actions for improvement.
- Prepare for inspections from regulatory bodies (eg. MHRA and Home Office) and provide support for regulatory submissions.
- Coordinate and support on-site audits conducted by external providers
- Ensuring the appropriate CAPAs identified and implemented with appropriate timescales.
The ideal candidate for the GDP Quality Manager role will have the following background:
- Degree qualified and have good experience in a GDP environment.
- Must have worked within the Pharmaceutical, or related sectors.
- You will have strong pharmaceutical wholesale experience and have a prior experience ensuring strong GDP processes are put in place across the business
- You will have prior experience in developing Quality Management System's (eQMS) to ensure compliance with GDP standards.
Keywords:
GDP Quality Manager, GDP Compliance Manager, Quality Manager, QA Manager, Quality Assurance Manager, Deputy RP, Deputy Responsible Person, RP, WDA, WDA(H), GDP, Good Distribution Practice