You will like
Working in Haverhill Surrey UK for this leading multinational pharmaceutical firm on a mission to help people live life without limits!
You will like
The Computer Systems Validation CSV Team Leader role itself where you will
- Manage the performance of individuals and the overall team to meet defined priorities and objectives.
- Actively develop team members technical ability, productivity and key competencies.
- Manage priorities for individuals and team, and addresses conflicts as necessary.
- Understand the stakeholders for the role and team and meets their communication and performance requirements and expectations.
- Foster and develop a culture of safe working and safety best practice within own team and the department.
- Develop an environment of trust, openness and collaboration within team and department.
- Provide 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.
- Review and approve validation deliverables and provides guidance in their creation.
- Identify compliance gaps within their own area of responsibility and proactively works towards their remediation.
- Keep up to date on regulations and global quality documents updates with respect to CSV and evaluates the impact on-site activities.
- Maintain a constant state of inspection readiness within an area of responsibility and contributes to this process across the department.
- Support all site audits (internal, and third parties) and inspections both directly and indirectly.
- Drive a culture of continuous improvement within the direct team and the wider department.
- Maintain Validation systems and processes to the standards.
- Identify and highlight quality risks and actively participates in their resolution.
- Review and oversites of qualification and validation for timeliness, content and conclusions.
- Take ownership and manages all Phenix entities relating to direct group (events, CAPA, CCs etc)
- Ensure own and teams training records are complete and up to date.
- Maintain local computer system inventory and CSV SharePoint.
- Manage scheduling of Periodic and Security Reviews and ensuring adherence to these schedules.
- May supervise other staff and contractors as required to manage workload.
- Ensure HSE risk assessments are in place and regularly reviewed for all team activities
You will have
To 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 get
As Computer Systems Validation CSV Team Leader, you will enjoy Competitive FTC Rate + Relo + Package
You can apply
To Computer Systems Validation CSV Team Leader by pushing the button on this job posting (recommended), by sending CV in confidence to anthony@macstaff.co.uk , or give me a call at 01275 331307.