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We are seeking a Validation Associate to join our biopharmaceutical client on a 12-month contract. This role is fully remote/EST hours.
Summary:
The Validation Associate will support the IT environment with oversight responsibilities by the our Client’s Global Quality organization.
Key Responsibilities
- Implementing the Data Integrity standards, policies and procedures within allocated areas of the business
- Prior knowledge and experience in Validating SAP, Veeva, Pharmacovigilance systems.
- Author and review of validation packages and gap assessment of such for deliverables received from vendors providing testing and validation of Apellis SaaS systems
- Management of the validation life cycle
- Review and management of the various validation projects supporting the GxP systems
- Documentation, execution and review of testing required to meet the intended use of the system
- Maintenance of the validation documents in a controlled environment and review at all times against inspection readiness compliant with 21 CFR Part 11, Annex 11 and other guidance and regulations supporting CSV
- Management and execution of system periodic reviews
- Coordinate with various functions, business owners and IT to maintain validated state of systems
- Identify, plan and outline responsibilities for validation efforts across GxP systems
- Provide risk and impact assessments as required for change control and system updates
Requirements
Education, Registration, Advance Training &/or Certifications:
- Bachelor’s degree (B.A./B.S.) or equivalent in computer science, scientific or related discipline.
Experience, Expert Knowledge &/or Competencies:
- 7+ years related experience in Computer System Validation.
- Knowledge of regulatory requirements and experience working in a GxP and CSV requirements
- Hands on experience in authoring validation documents and associated procedures (SOPs)
- Strong interpersonal verbal and documentation skills
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