Contact one of our consultants
Quality Systems and Validation Manager in Wiltshire
- 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.