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CSV Specialist

Juncos, PR
CSV SPECIALIST
Description:

Searching for Validation Specialist with experience in the pharmaceutical industry with CSV.  The candidate must have solid GMP and regulatory experience with expertise in computer system validation (CSV).

Responsibilities
  • Must have experience generating and executing computer system validation (CSV) change controls process and validation protocols.
  • Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement validation standards on a daily basis
  • Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards
  • Generate new specifications based on new regulations required by the implementation of a new manufacturing process.
  • Generates, executes, reviews, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
  • Prepares and coordinate qualification activities and validation activities.
  • Communicate with the staff and management on ways of implementing plans and recommendations.
Skills and Specifications
  • Minimum of 4 years of experience
  • CSV experience is required
  • Strong Technical Writing Skills
  • Project management experience is a plus
  • Problem Solving
  • Sense of urgency
  • Detail Oriented
  • Willing to work overtime including weekend depending ion the nature of work available.
  • Able to work with minimum or no supervision
  • Strong interpersonal skills and must work in a team
  • Fully Bilingual (English and Spanish)
Requirements
  • Minimum BA/BS in Computer Science, Electrical Engineering Systems, or equivalent experience and/or field of study
Integrated Technology and Compliance Services is an Equal Opportunity Employer

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