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Computer Software Validation Specalist

Computer Software Validation Specalist

Job Title: Computer Software Validation Specalist
Contract Type: Permanent
Location: Mannheim
Industry:
Salary: TBD on application
Start Date: 2019-08-19
Reference: J16332 AB-1
Contact Name: Alex Butcher
Contact Email: alex.butcher@nextphaserecruitment.com
Job Published: August 20, 2019 16:16

Job Description

One of the fastest growing and recognizable Informatics Solutions companies in the world is seeking a Software Validation expert to join them in Ludwigshafen, Germany. This role will be fully office based. An international company with offices worldwide, they have a reputation for being experts in their field regarding laboratory informatics systems. You will be required to carry out on-site testing and validation of software systems to improve the quality and document compliance of the client’s computer systems with applicable regulations.
 
Working predominantly with a major client in the Mannheim/ Ludwigshafen region, this role will involve validating software systems for a variety of global leading pharmaceutical and life science organizations.
 
Requirements;
  • Experience of working in a Validation role within the pharmaceutical/ life science industry
  • Demonstrable specific expertise in Computer Systems Validation (CSV)
  • Experience of user requirements, system requirements and functional requirements specification
  • Develop and execute validation and test plans such as IQ, PQ, and OQ
  • Experience of planning and managing delivery of validation projects and procedures to meet current GMP regulations and guidelines, industry best practice and company policy.
  • Experience of validating electronic records such as 21 CFR Part 11, and Annex 11
  • Able to manage stake holders effectively