CSV Team Leader

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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