Do you have a degree or significant experience in a QA Regulatory function focusing on computerised systems?
Are familiar with carrying out audits and inspections in several operational area?
Our Client is looking for a Senior Quality Consultant based site to Plan, conduct & report Quality Assurance activities, especially those related to computerised systems to assure compliance with GLP/GCP, company policies & SOP's.
Your main responsibilities will be:
Carrying out the following Audits & Inspections activities in a selection of Operational areas
Conduct Operational audits of computerised systems
Review of Computerised system validation documents including change controls
Organising, performing & reporting Facility Inspections / Systems Audits.
Maintaining an up to date knowledge of software applications necessary to perform QA procedures
Being the QA signatory for relevant QA Statements
Approving inspection planning prior to allocation.
Planning departmental process-based inspections
Modifying Company and QA SOPs for submission to the approval process
Reviewing SOPs including those related with data integrity and computerised systems
Lead Root Cause Analysis and subsequent mitigation.
Review quality risk assessments and subsequent mitigation especially those associated with data integrity of computerized systems
Assisting in the delivery of the training programmes for all QA staff.
QA Business Partner to identified Operations and Support sectors of CRS particularly IT and Computerised systems
What do you need:
A Degree or equivalent and extensive experience in a QA regulatory function especially those associated with data integrity of computerized systems
Able to be self- sufficient in a technical, scientific or specialised field gained through broad and deep experience built on concepts and principles, or through wide exposure to complex practices and precedents
To drive, motivate and communicate risks to others in relation to continuous improvement opportunities.
Seeks to understand the needs of all parties when assessing quality issues and risks
Able to think outside the box and deal with ambiguity
To proceed with your application for this role, simply apply to this advert, or alternatively you can send your most recent up to date CV
Please note, only successful candidates will be contacted. All successful applications are subject to S3 Science's stringent vetting and security checks.
S3 Science is proud to be an equal opportunities employer and is committed to creating a diverse environment. All qualified applicants will receive consideration for employment without regard to race, colour, religion, gender identity or expression, sexual orientation, national origin, genetics, disability, age or veteran status.