CSV Team Leader
Responsibilities for a CSV Team Leader
- 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 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.
- 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.
- Typically a graduate or equivalent in a science, engineering, computing or pharmaceutical related subject area – desirable