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CSV Team Leader

Macstaff
Job LocationHaverhill
EducationNot Mentioned
Salary£120,000 - £140,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

You will likeWorking in Haverhill Surrey UK for this leading multinational pharmaceuticalfirm on a mission to help people live life without limits!You will likeThe Computer Systems Validation CSV Team Leader role itself where you will

  • Managethe performance of individuals and the overall team to meet defined priorities and objectives.
  • Actively developteam members technical ability, productivity and key competencies.
  • Managepriorities for individuals and team, and addresses conflicts as necessary.
  • Understandthe stakeholders for the role and team and meets their communication and performance requirements and expectations.
  • Fosterand developa culture of safe working and safety best practice within own team and the department.
  • Developan environment of trust, openness and collaboration within team and department.
  • Providesupport and guidance to site projects and operations to meet the quality and compliance requirements of the site and the wider company with respect to CSV.
  • Reviewand approvevalidation deliverables and provides guidance in their creation.
  • Identifycompliance gaps within their own area of responsibility and proactively works towards their remediation.
  • Keepup to date on regulations and global quality documents updates with respect to CSV and evaluates the impact on-site activities.
  • Maintaina constant state of inspection readiness within an area of responsibility and contributes to this process across the department.
  • Supportall site audits (internal, and third parties) and inspections both directly and indirectly.
  • Drivea culture of continuous improvement within the direct team and the wider department.
  • MaintainValidation systems and processes to the standards.
  • Identifyand highlightquality risks and actively participates in their resolution.
  • Reviewand oversites of qualification and validation for timeliness, content and conclusions.
  • Takeownership and manages all Phenix entities relating to direct group (events, CAPA, CCs etc)
  • Ensureown and teams training records are complete and up to date.
  • Maintainlocal computer system inventory and CSV SharePoint.
  • Managescheduling of Periodic and Security Reviews and ensuring adherence to these schedules.
  • May supervise other staff and contractors as required to manage workload.
  • EnsureHSE risk assessments are in place and regularly reviewed for all team activities
    • You will haveTo be successful as Computer Systems Validation CSV Team Leader you will typically be a graduate or equivalent in a science, engineering, computing or pharmaceutical related subject area, however you will certainly have the following:
  • Strong knowledge of working within a Quality Management System and cGMP and experience of working within a cGMP environment.
  • High level of qualification/validation knowledge.
  • Ability to develop good relationships with customers and stakeholders.
  • Experience of working within a quality role.
  • Strong written and verbal communication skills.
  • Ability to motivate, engage and develop individual team members.
  • Awareness of statistical analysis techniques and software and ongoing development of knowledge in this area.
  • Understanding of data integrity principles.
  • Understanding of current industry requirements of cGMP, Annex 11, GAMP, 21 CFR Part 11.
  • Experience of working on GAMP related projects for multiple aspects of IT and/or process control systems.
  • Current regulatory knowledge in the field of computer systems validation.
    • You will getAs Computer Systems Validation CSV Team Leader, you will enjoy a generous salary, £120K-£140KNeg + Relo + PackageYou can applyTo Computer Systems Validation CSV Team Leader by pushing the button on this job posting (recommended), by sending CV in confidence to , or give me a call at .

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