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Responsible for defining quality requirements for validation/qualification of equipment, facilities, utilities, test methods and computerised systems for the industrialisation of products and processes Works in conjunction with Quality Projects Manager to take projects forward to industrialisation.
Responsible for review of validation/qualification documentation to support changes/improvements to processes Responsible for providing quality guidance to Technical/Operations
Report to Head of Quality on progress with activities, provision of information (e.g. input to Monthly Business Reports, Quarterly Reports) and escalation of issues
Design/produce reports and metrics to identify trends and areas of opportunity Drive initiatives to deliver measurable performance improvements.
Define and develop processes and procedures in area of expertise
Act as Subject Matter Expert for area of expertise by maintaining knowledge of regulations and awareness of regulatory expectations and customer requirements
Perform document approvals in area of responsibility and design and implement improvements to documentation used.
Provide input on request for Annual Operating Plan (budget/capital expenditure and headcount)
Lead team members on a day to day basis. Establish training plans for all reports. Perform annual appraisals Schedule and plan activities across team members and monitor progress Establish regular meetings with team members. Develop a Continuous Improvement culture within the team
Knowledge and Expertise
Sound knowledge of current regulatory requirements for validation as well as experience with Best Practice Proven experience working in a validation role.
No requirements but ideally degree level education in scientific discipline
Demonstrate commitment to Core Values (Associates, Safety and Quality, Customer Satisfaction, Investment and Innovation) Be a role model for Quality across the organisation by doing things right and doing the right things Complete personal Training and Development Plan and seek opportunities to grow and learn Comply with policies and procedures and fulfil roles
Communicate effectively both verbally and in writing Identify areas for improvement in daily work Complete work to agreed priorities and meet due dates. Report to those in authority if any timelines are likely to be missed. Listen to performance feedback provided and take any necessary action Perform any other duties as requested by those in authority.
To apply for this position, candidates must be eligible to live and work in the UK
Matchtech is acting as an Employment Business in relation to this vacancy.