Validation Lead

1 week ago

Petersfield, Hampshire, United Kingdom Insignis Talent Full time

Validation Lead - Up to £64k

Petersfield


My client is a global leading manufacturer and looking for a Data Integrity and Validation Lead to join an experienced and committed team.


The primary role of this position is to ensure that validation and data integrity activities are compliant with applicable validation and data Integrity (DI) cGMP regulations across the site.

It is integral that this role provides key support to the Site Leadership Team for all validation and DI requirements and assists the site in key compliance activities and responsibilities.


Key Responsibilities:

  • Lead Data Integrity Rollout strategy for plant.
  • Direct the efficient and effective execution of DI requirements across the site/campus
  • Liaise with relevant crossfunctional team to coordinate DI activities to leverage scale and maximize efficiencies
  • Collaborate with other DI Site Leads to share best practices and harmonize processes across the global manufacturing sites
  • Initiate and manage any DI work processes required for assigned program to ensure site compliance
  • Resolve timeline issues related to executional deliverables and develop tactical plans when necessary to bring back on track
  • Ensure Day to Day discipline to project plan and call out any risk of timeline gaps
  • Ensure implementation of continuous improvement and process improvement programs
  • Establish current state and work to drive remediation efforts and sustainable solutions
  • Manage the DI compliance on all GxP Computerized Systems
  • Instruments and Equipment
  • Lead and manage the effective execution and implementation of computerized projects across the entire site including QA Labs

Qualifications:

About You:

  • Experience in staff management with proven ability to manage and collaborate in a multilocation
  • Must be an excellent team player with strong analytical skills, negotiating and communication skills
  • Strong program management skills including followup and organizational skills
  • Ability to use computer systems necessary to meet objectives including Microsoft Office, MS project, SAP
  • Experienced in Supply Chain processes and working across multiple business functions at site level to rollout DI and validation requirements.
  • Strong ability to provide visibility and management of priorities and risks and opportunities for DI and validation related activities and elevated to leadership where appropriate.
  • Strong background working with corporate functions such as Global R&D and Global QA to ensure robust SOPs and Work Instructions are in place to ensure compliant GxP systems.
  • Experienced in writing SOPs and Work Instructions and other Quality System Documents.
  • Knowledge of GxP (Good Clinical/Manufacturing/Documentation practices)

Salary:
Up to £64,000.00 per year

Schedule:

  • Monday to Friday

Work Location:
One location

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