CSV Engineer
CSV Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Looking for someone who has done and CSV. Must understand the business of clinical. We are seeking a versatile professional with the ability to review documents meticulously and
support the creation of validation deliverables as needed. The ideal candidate will thrive in a challenging environment and possess the skills to effectively communicate the importance of validation processes to stakeholders outside the validation team.
Responsibilities:
- Conduct thorough reviews of validation documents.
- Assist in the creation and development of validation deliverables.
- Adapt to and excel in a dynamic and challenging work environment.
- Clearly articulate the significance of validation processes to nonspecialist audiences.
- The Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of Clients vendors and computerized systems.
- Participate in computer system and vendor audits for review of their Quality Management System SDLC including validation and data integrity controls.
- Review CAPA and verification of CAPAs of system and vendor audits.
- QA approver for internal validation efforts.
- Act as liaison to the business for guidance and consultancy on software validation.
- Support health authority audits/inspections for inspection readiness.
- Bachelors degree in associated functional disciplines including IT Data Sciences and others.
- Software development familiarity with both Agile and Waterfall methodology.
- Minimum 35 years experience in pharmaceutical industry or similar.
- Minimum 13 years experience Vendor / Computerized System Validation (CSV) Auditing experience.
- Knowledge of regulations governing software validation and development.
- Knowledge of GCP/GMP is preferred.
- Must have professional communications skills strong independent time management skills and the ability to manage multiple projects concurrently.
- Ability to Travel.
- Hybrid must be a local candidate willing to come on site 23 days a week in Nutley.
Employment Type
Full Time
