CSV Consultant
- London, England (GBR)
- £500 - £625 Per Day
- 6 Months
- Start date: ASAP
- Ref: TBC
- computer systems validation
- quality management system
- compliance
- pharmaceutical manufacturing
- quality assurance
- pharmaceutical
- documentation
- automation
- manufacturing
- regulations
CSV Consultant
6 Months
Brentford (Remote Working)
£550 - £625p/d max via Umbrella
Responsibilities:
• Preparation and approval of validation documentation or management of the process (fulfilling the
Quality Assurance role) in accordance with the relevant processes (e.g. Quality Management System)
• Monitoring project and/or support activities to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes
• Providing and/or facilitating quality assurance oversight for the automation of business process associated with pharmaceutical manufacture and distribution
• Project problem identification/resolution/avoidance; typically involving ongoing interaction with management teams within Tech functions, site and local operating company Quality organisations, and Third Party suppliers/service providers
• Participating in the deployment, maintenance and inspection support of multiple global projects including responsibility, with management oversight, for the developing solutions that maintain compliance and keep validation on schedule and on budget
• Ensuring issues/risks are identified, mitigated and/or escalated for items that could adversely impact quality compliance associated with projects/systems
• Provision of performance measures to drive performance and continuous improvement
• Performing periodic compliance reviews of Tech systems
Skills & Experience
• Broad experience in providing validation, deployment, change management, and inspection support of large, complex, computerised systems
• Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles and expectations
• Technical knowledge to support quality and validation decision making for GxP analytical, manufacturing, distribution and IT computerized systems
• Demonstrated ability to interpret and apply company guidelines, principles and expectations such that systems are validated in proportion to the risk they present to patient safety and product quality
• Demonstrated ability to handle multiple priorities and complete work within agreed timescales e.g. key QA role deliverables
• Demonstrated knowledge of regulatory inspection process including specific queries of computer systems validation/compliance activities and documentation
• Effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in "win-win" outcomes to achieve business goals and objectives
Desirable
• Working knowledge of ‘New Technologies’ within a regulated environment:
o Robotic Process Automation
o Artificial Intelligence/Machine Learning
o Biometrics and Electronic Signatures
o Cloud (IaaS, PaaS, SaaS)
o Automated Testing Tools
