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CSV Team Leader

Job Title: CSV Team Leader
Contract Type: Contract
Location: Haverhill
Industry:
Salary: 120000 - 140000
REF: 1736
Contact Name: Ray Gray
Contact Email: ray@1ststoprecruitment.co.uk
Job Published: 20 days ago
TEAM Member
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TEAM Member Email info@1ststoprecruitment.co.uk
TEAM Member Phone Number 01440 763021
Member Contact Alex Gaforg-Pinkney
Contact Phone Number 01440 763021
Approximate Total Fee:
Split Fee Terms:

Job Description

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.

Qualifications Required

  • Typically a graduate or equivalent in a science, engineering, computing or pharmaceutical related subject area – desirable