DATA INTEGRITY SITE MANAGER

OevelIIndustrie pharmaceutique

Description de fonction

As a DATA INTEGRITY SITE MANAGER you will be responsible of the following tasks:

  • you will lead data integrity rollout strategy at the site 
  • you direct the efficient and effective execution of Data Integrity requirements across the site 
  • you are a liaison with relevant cross-functional teams to coordinate DI activities to leverage scale and maximize efficiencies accordingly. 
  • you collaborate with other DI site program managers to share best practices and harmonize processes across the global mfg sites 
  • you initiate and manage any DI work processes required for assigned program (including change management) to ensure site is compliant. 
  • you resolve timeline issues related to executional deliverables and you develop tactical plans when necessary to bring back on track.
  • you ensure day to day discipline to project plan and you call out any risk of timeline gaps
  • you ensure implementation of continuous improvement and process improvements programs
  • you are responsible for establishing current state and you work to drive remediation efforts and sustainable solutions
  • you are responsible for managing the DI compliance on all GxP Computerized systems - instruments and equipment
    • Individual is responsible for technical management of all GxP computerized systems used at the site. The responsibility would include working with individual scientific, manufacturing system vendors, and drafting - and maintaining - current compliant system documentation, compliant training procedures and documentation etc. This responsibility also requires developing and documenting the processes for the equipment/instrument management role. 
    • You provide leadership to ensure that all initiatives are appropriately and effectively managed, documented and monitored for optimum efficiency and effective roll out.
    • you coordinate all future system rollouts, scientific applications and new system upgrades
    • you coordinate with plant operations team and site QA to conduct periodic,  hands on audits and an annual physical inventory verification of computerized systems throughout the site to ensure that systems are current and continue to function appropriately for current use in the company.
    • You coordinate, execute and document all System User Verification for data integrity and compliance requirements.
    • You ensure all GxP applicable systems have CSV documentation and procedures in place. 
    • You ensure all computerized systems have appropriate back up procedures 
  • You lead and manage the effective execution and implementation of computerized projects across the entire site including QA labs 
  • You ensure adherence to System Development and Life cycle (SDLC), FDA Validation, CFR 21 Part 11 and Change control management processes requiring a detail knowledge of the quality systems inclusive of Change Control, CAPAs and deviation procedures. 
Profil
  • You have a university degree in a technical discipline (engineering, science, information technology...) or equivalent by experience. 
  • You are experienced in supply chain processes and systems in a Fortune 500 CPG company. 
  • You are experienced in managing various laboratory equipment and systems in a highly dynamic landscape. 
  • You are experienced in writing SOPS and Work Instructions and other Quality System Documents. 
  • You have knowledge of GxP, FDA Validation and CFR 21 Part 11.
  • Knowledge of various software applications and SAP ERP is a plus.
  • Knowledge in data infrastructure / security background is a plus as well as any data integrity & integration experience. 
  • You are communicative and a teamplayer
Descriptif de l’organisation et du département

Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium, the Netherlands and Dubai, we provide support to companies who need experienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

For one of our pharma clients in Geel we are looking for a DATA INTEGRITY SITE MANAGER (M/F). 

Offre

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Avez-vous des questions?
Bénédicte Joret Technical Projectsourcing Select Projects +32 3 203 50 88
DATA INTEGRITY SITE MANAGER Informations offres d'emploi
63052
zz archive Engineering / Technics
Project Sourcing
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