Software Validation Quality Nutley Nj Hybrid
Canada, Canada
Job Description
Job Title: Software Validation Quality
Location: Nutley NJ - Hybrid
Duration: 12 monthsWe are happy to sponsor TN Visa for candidates with Canadian passports:The Software Validation Quality Consultant will work closely with the Clinical Quality Assurance Systems Lead to support internal validation efforts and audits of our vendors and computerized systems.Key Responsibilities:
- Conduct audits of computer systems and vendors, assessing their Quality Management System, SDLC, validation, and data integrity.
- Review and verify CAPAs from audits.
- Approve internal validation efforts.
- Provide guidance on software validation.
- Support inspection readiness for health authority audits.
- Bachelor\'s degree in IT, Data Sciences, or related field.
- 3-5 years of experience in the pharmaceutical industry or similar.
- 1-3 years of experience in CSV Auditing.
- Familiarity with Agile and Waterfall methodologies.
- Knowledge of software validation regulations.
- Preferred knowledge of GCP/GMP.
- Strong communication and time management skills.
- Clinical quality assurance
- Validation
- SDLC
- CAPA
- Agile and Waterfall methodologies
- CSV
- GCP/GMP
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Job Detail
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Job IdJD2330275
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationCanada, Canada
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EducationNot mentioned