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QA Computer Systems Validation (CSV) Coordinator | Biopharma | Southern Israe (3877)

Gefen Recruitment (גפן השמות)South District, IsraelNot specifiedFull-timeSeniority: Not specified

Posted 20 days ago · 0 applicants

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The role in plain words

Must-have
  • B.Sc. in Engineering or Life Sciences (Chemical Engineering or Biotechnology Engineering preferred)
  • Fluent Hebrew and English
  • Strong communication skills and the ability to work across multiple interfaces
Nice-to-have
  • 1–3 years of experience in QA, CSV or computerized systems validation
  • Experience writing validation documentation

Extracted from the job description · kept up to date automatically

Who this suits

Full job description

Original listing · kept for reference

Looking to build your career in Quality Assurance and Computer Systems Validation within a leading biopharmaceutical company?

We're looking for a QA Computer Systems Validation (CSV) Coordinator to join a multidisciplinary team at a cutting-edge manufacturing site. This is an excellent opportunity for professionals with up to 3 years of experience, as well as engineering graduates with a strong interest in computerized systems and GMP-regulated environments.

Key Responsibilities:

• Review and approve validation documentation for computerized systems, engineering systems, and process control systems (URS, FS, IQ/OQ/PQ, STP and related documentation)

• Support validation activities for software, hardware, equipment, and infrastructure

• Review and approve SOPs and controlled documentation

• Participate in Risk Assessments and GAP Analyses

• Support engineering projects as the QA representative

• Review and approve validation deviations and change controls

• Work closely with QA, Engineering, Manufacturing and IT teams

Requirements:

✔ B.Sc. in Engineering or Life Sciences (Chemical Engineering or Biotechnology Engineering preferred)

✔ 1–3 years of experience in QA, CSV or computerized systems validation – an advantage

✔ Experience writing validation documentation – an advantage

✔ Fluent Hebrew and English

✔ Strong communication skills and the ability to work across multiple interfaces

✔ Experience in the pharmaceutical or medical device industry – an advantage

✔ Familiarity with GMP, Annex 11 and 21 CFR Part 11 – an advantage

Recent graduates are also encouraged to apply if you have a strong technical aptitude, excellent analytical skills, and a genuine interest in Quality Assurance and computerized systems within a GMP-regulated environment.

About Gefen Recruitment (גפן השמות)
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Gefen Recruitment (גפן השמות)
Posted 20 days ago · 0 applicants
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