Quality Systems and Validation Manager in Wiltshire

Duties/Responsibilities:

  • 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).

 

Qualifications/Experience

  • 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.

Reference

LM - QSVM

Location

Wiltshire
SP4 0JQ

Salary

Daily Rate
500.00-563.00

Apply for this job

Register your C.V. and apply for this job

Apply Now

Share this job