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QA CSV Engineer

Date Posted: February 2, 2024

Job Description

As a QA CSV Engineer, you will focus on the validation of computerized systems used in pharmaceutical environments to ensure they meet all quality and regulatory requirements. Your responsibilities will include developing validation plans, conducting tests, and documenting results to ensure systems are consistently producing quality results. Your expertise will be vital in maintaining the integrity and compliance of software and systems that are critical to pharmaceutical manufacturing and quality control.

Key Responsibilities

  • Develop and implement validation plans for computerized systems to ensure they meet all required quality and regulatory standards.
  • Conduct risk assessments for computerized systems and identify potential quality issues.
  • Design, execute, and document test cases and scenarios to verify the functionality and performance of computerized systems.
  • Collaborate with IT, quality assurance, and other relevant departments to ensure comprehensive validation efforts.
  • Review and analyze validation test data to ensure systems are operating as intended.
  • Prepare and maintain validation documentation, including test protocols, reports, and validation summary reports.
  • Ensure that computerized systems are in compliance with GxP regulations and guidelines, including 21 CFR Part 11 and Annex 11.
  • Provide training and support to end-users on the proper use of computerized systems and the importance of compliance.
  • Stay up-to-date with industry trends, regulatory requirements, and best practices in computer system validation.

Required Qualifications and Skills

  • Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
  • Minimum of 3 years of experience in computer system validation within the pharmaceutical or a related regulated industry.
  • Strong understanding of GxP regulations, including GMP, GLP, and GCP, and specific knowledge of 21 CFR Part 11 and EudraLex Annex 11 requirements.
  • Experience with validation of ERP, LIMS, MES, and other pharmaceutical industry-specific software is highly desirable.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Strong documentation skills, with the ability to produce clear and detailed validation documents.
  • Effective communication skills, both written and verbal, with the ability to collaborate across various departments and levels of the organization.
  • Proficiency in Microsoft Office and experience with project management tools.
  • Self-motivated with the ability to work independently and as part of a team.

If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E

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