CSV Team Leader

Location: Haverhill, Suffolk Salary: £50000 - £60000 per annum
Sector: Pharmaceuticals Type: Permanent
Contact: Matt Henocq Job Published: 7 days ago

CSV Team Leader

Purpose of the role:

  • Provides leadership and management of the CSV team to meet defined priorities and the overall objectives of the department
  • Is responsible for coordinating and for providing validation expertise in the lifecycle management of all aspects of computer system validation, qualification, data integrity activities at Haverhill.
  • Ensures compliance of validated computerised systems with requirements set forth in relevant procedures as per GAMP and cGMP.
  • Ensures approval of qualification or validation protocols and reports for computerised systems.

Key responsibilities:

  • Manages the performance of individuals and the overall team to meet defined priorities and objectives
  • Actively develops team members technical ability, productivity and key competencies
  • Manages priorities for individuals and team, and addresses conflicts as necessary
  • Understands the stakeholders for the role and team and meets their communication and performance requirements and expectations
  • Fosters and develops a culture of safe working and safety best practice within own team and the department
  • Develops an environment of trust, openness and collaboration within team and department
  • Provides support and guidance to Haverhill site projects and operations to meet the quality and compliance requirements of the site and the wider company with respect to CSV.
  • Reviews and approves validation deliverables and provides guidance in their creation.
  • Identifies compliance gaps within their own area of responsibility and proactively works towards their remediation.
  • Keeps up to date on regulations and global quality documents updates with respect to CSV and evaluates the impact on site activities.
  • Maintains a constant state of inspection readiness within area of responsibility and contributes to this process across the department
  • Supports all site audits (internal, and third parties) and inspections both directly and indirectly
  • Drives a culture of continuous improvement within direct team and the wider department
  • Maintains Validation systems and processes to the standards of my clients Quality Documentation
  • Is the pyramid owner for CSV documents
  • Identifies and highlights quality risks and actively participates in their resolution
  • Reviews and oversites of qualification and validation for timeliness, content and conclusions
  • Takes ownership and manages all Phenix entities relating to direct group (events, CAPA, CCs etc)
  • Ensures own and teams training records are complete and up to date
  • Maintains local computer system inventory and CSV sharepoint.
  • Manages scheduling of Periodic and Security Reviews and ensuring adherence to these schedules.
  • May supervise other staff and contractors as required to manage workload.
  • Ensures HSE risk assessments are in place and regularly reviewed for all team activities

Knowledge skills and experience required:

  • 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

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