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Soortgelijke vacatures omgeving Beerse (BE).

CSV & DI Squad Lead Beerse (BE) Panda International

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Gevraagd

  • 37 - 40 uur

Aanbod

  • Tijdelijk contract
 

Vacature in het kort

Beerse (BE)
Join a leading pharmaceutical site as a Squad Lead for Computer System Validation and Data Integrity. Collaborate with local process owners to align CSV and DI practices with industry standards. Focus on risk-based methods and regulatory compliance in a GMP environment. Lead projects, manage resources, and drive change management. Enjoy dynamic project work and make a lasting impact on compliance and innovation. Competitive compensation and a strategic role await you. Discover more about this exciting opportunity by reading further.
 

Over het bedrijf

Panda International
Bedrijfsprofiel
 

Volledige vacaturetekst

Vacancy: Squad Lead – Computer System Validation (CSV) & Data Integrity (DI)

Location: Geel region, Belgium
On-site presence: Minimum 80% required
Employment type: Contract / Project-based
Duration: 6 Months + option for renewal


About the Role

We are currently seeking an experienced Squad Lead for Computer System Validation (CSV) and Data Integrity (DI) for a leading pharmaceutical manufacturing site in the Geel region. In this role, you will co-lead, alongside local process owners, the alignment of existing CSV and DI practices with current industry standards. A strong focus will be placed on risk-based methodologies, regulatory compliance, and sustainable implementation of best practices within a GMP-regulated environment.


Key Responsibilities
  • Provide direction on CSV & DI best practices, applying science-based, risk management approaches

  • Oversee multiple ongoing projects and manage both internal and external resources (contractors)

  • Ensure the quality and regulatory compliance of project deliverables, in close collaboration with QA

  • Drive change management initiatives to ensure long-term adoption of improved processes

  • Mentor and coach the Local Process Owner (LPO) to elevate knowledge and adherence to industry standards

Your Profile
  • Strong expertise and hands-on experience with CSV and data integrity in a pharmaceutical manufacturing environment

  • Preferably experienced in an API setting, with knowledge of DeltaV, PI, PCS7, and alarm management best practices

  • In-depth knowledge of FDA and EMA expectations on CSV and DI, with practical experience using risk-based validation approaches and documentation

  • Excellent project management skills, including planning, organizing, and coordinating

  • Demonstrated ability to lead teams in complex and fast-paced environments

  • Skilled in coaching, change management, and training

  • Able to navigate across multiple organizational levels and influence without direct authority

  • Language requirements: English (required), Dutch (preferred)

What’s Offered
  • A strategic and high-impact role within a global pharmaceutical environment

  • Dynamic and multidisciplinary project work

  • Competitive compensation (freelance or fixed-term contract possible, depending on your profile)

  • Opportunity to make a lasting contribution to compliance, quality, and innovation

Interested or want to learn more?
Please get in touch or send your CV to via de button "Solliciteer nu" op deze pagina..

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