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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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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