CSV Specialist
Job Description:
Pay Range 50hr - 55hr Provide compliance leadership, direction and oversight to project teams in the area of Computer System ValidationResponsible for the quality oversight of GxP regulated computerized systems (e.
gmanufacturing plant systems, laboratory systems and enterprise applications)Manage the release of regulated systems for GxP production useParticipate in the review and approval of technical changes, Quality Incidents, CAPAs and proceduresContribute to establishing and deploying processes, compliance-driven standards, and procedures (as required), determining boundaries for harmonization and alignment versus differentiation, and ensuring they remain current with FDA and global regulatory requirements for GxP computerized systemsParticipate in evaluating the current Crucell quality systems for GxP computerized systems, and implement improvements to comply with the current FDA/EU standardsProvide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 210, 211, 58, 820, 11 and EU Annex 11 EU)In addition, this individual will lead and participate in project teams and may participate in regulatory inspections and client audits Minimum
Qualifications:
Bachelors or Masters degree in science, computer science, or relevant areaThorough knowledge of cGMP, in manufacturing and R&D within GxP regulated industriesA minimum of 7 years relevant working experience in a pharmaceutical or biotechnology company of which preferably 3 years in validation or QC, and in QA/CSVIn-depth knowledge of computerized quality systemsExperience with GMP inspections Competences:
Communicative skillsNegotiation skillsConvincingTeam playerAccuracyProblem solverSkills:
CSV, 21 CFR part 11, Data integrity, Archiving.
Recommended Skills Auditing Biotechnology Communication Information Technology Leadership Manufacturing Estimated Salary: $20 to $28 per hour based on qualifications.
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