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CSV Team Lead

AMS Contingent Team
Job LocationHaverhill
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

Alexander Mann Solutions (AMS) is the worlds leading provider of Talent Acquisition and Management Services. We deliver award-winning solutions to over 65 outsourcing clients and consulting services to hundreds more. Our Contingent Workforce Solutions (CWS) service acts as an extension of our clients recruitment team and provides professional interim and temporary resources.Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference on patients daily life, wherever they live and enable them to enjoy a healthier life.On behalf of this organisation, AMS are looking for a CSV Team Lead for a 12 Month contract based in Haverhill.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.
    • As a CSV Team Lead you will be responsible for:
  • 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
    • What we require from the candidate:
  • Proven management experience in a similar role
  • High level of qualification/validation knowledge
  • 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.
    • IR35 Status: This role has been assessed as inside of IR35.If you are interested in applying for this position and meet the criteria outlined above, please click the link to apply and we will contact you with an update in due course.Alexander Mann Solutions, a Recruitment Process Outsourcing Company, may in the delivery of some of its services be deemed to operate as an Employment Agency or an Employment Business Required skills
  • Team Leader
  • Computer System Validation
  • CSV
  • Manager

    • Keyskills :
    Team Leader Computer System Validation CSV Manager

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