|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.
- 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
Services advertised by Gold Group are those of an Agency and/or an Employment Business.