Quality Systems and Validation Manager
Our Client ensures that innovative science and technology contribute to the defence and security of the UK. They are looking to recruit a Quality Systems and Validation Manager.
- Author/Review/Approve validation deliverables.
- Design and manage Validation Master Plan strategies
- Provide CSV oversight to IT programmes assuring compliance in-line with but not limited to: FDA, MHRA, GxP and company standards.
- Ensure that standards regarding Computer Systems Validation are implemented and adhered to.
- Work with business users and IT staff to identify and scope validation related processes.
- Identify compliance risks (with respect to Pharmaceutical industry regulations impacting computer systems) and proactively work with the business and IS to address these.
- Provide leadership to ensure that computer systems validation activities are implemented consistently across applicable programmes
- Coaching, Guidance and Assurance to project teams on computer systems validation deliverables.
- Influence and enforce Good Documentation Practice standards
- Work around change controls
- Attend governance, progress and review meetings when requested by the project team(s).
- Academic degree (or higher) in Biomedical/Life Sciences, Chemistry, Quality Management or similar experience
- A Member of Professional Body
- Strong personal competencies/skills as well as personal drive, and organisational skills.
- You should also be able to demonstrate excellent verbal and written communication.
- Experience and knowledge of working in a Good Manufacturing Practice environment, Good Laboratory Practice and Good Clinical Practice.
- Be able to communicate clearly and effectively to people of all levels within the company, customers and external suppliers.
- An ability to influence scientific and technical staff of GXP requirements Good IT Skills - proficient in MS Office Word, Excel, PowerPoint and Outlook is also required.
- If deemed inside IR35 - Please note that the client has determined that the off-payroll working rules will apply to this assignment and where a worker elects to provide their services through an intermediary (such as a personal services company) then income tax and primary national insurance contributions will be deducted at source from any payments made to the intermediary.
- If deemed outside IR35 - Please note that the client has determined that the off-payroll working rules will not apply to this assignment.
- Management Skills
- Computer Systems Validation
- SC clearance
- Pharmaceutical Background
Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.Report this job
"Office Assistant jobs in London"
'Saved search name'