Computer System Validation Specialist

2 weeks ago


South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time
Job Title: Computer System Validation Specialist

We are seeking a highly skilled Computer System Validation Specialist to join our team at Katalyst HealthCares & Life Sciences. As a key member of our IT Computerized System Validation (CSV) Department, you will be responsible for ensuring the quality and compliance of our computerized systems in accordance with cGMP, CFR Part, and Annex regulations.

Key Responsibilities:
  • Provide technical leadership and accountability for overall computer system validation efforts.
  • Ensure quality and compliance in accordance with established procedures and standards of the Quality Systems.
  • Generate, review, and approve base level documents such as Validation Plan, URS, FRS, DS, and SOPs.
  • Develop, implement, and maintain computer system validation-related controlled documents.
  • Assist with change controls, CAPAs, deviations, and exceptions required as part of system validation efforts.
  • Support system administrative & maintenance activities for Lab Systems.
  • Perform gap analysis & necessary remediation efforts on current computer systems to ensure compliance with Part and Annex regulations.
  • Collaborate/lead/participate in decision-making and make recommendations regarding the best options for validation of computer systems.
Requirements:
  • Minimum of Six (-) years or more in the pharmaceutical industry with GMP experience.
  • Understanding phases of Life Cycle Validation approach and practical working knowledge of computer system validation/computer software assurance requirements.
  • Demonstrate ability to effectively manage multiple projects/priorities.
  • Demonstrate excellent written and oral communication skills.
  • Effective time management and interpersonal skills.
Preferred Qualifications:
  • Relevant validation experience with Laboratory systems used within the pharmaceutical industry.

We offer a dynamic and challenging work environment with opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for computer system validation, we encourage you to apply for this exciting opportunity.



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