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IT Quality Validation Consultant
200 Metro Blvd. Nutley NJ USA 07110 Nutley, NJ 07110 US
Job Description
Target Pay Rate: 55-70/hr **salary will be commensurate with experience
Job Description:
Looking for someone who has done Validation in the clinical space. GCP 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.
Key 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 non-specialist audiences.
Hybrid - must be a local candidate willing to come on site - 2-3 days a week in Nutley.
The Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of client's vendors and computerized systems.
Essential Functions:
• 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.
Requirements:
• Bachelor’s degree in associated functional disciplines including IT, Data Sciences and others.
• Software development familiarity with both Agile and Waterfall methodology.
• Minimum 3-5 years' experience in Pharmaceutical industry or similar.
• Minimum 1-3 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
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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