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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 businessPrior 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 systemsManagement of the validation life cycleReview and management of the various validation projects supporting the GxP systemsDocumentation, execution and review of testing required to meet the intended use of the systemMaintenance 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 CSVManagement and execution of system periodic reviewsCoordinate with various functions, business owners and IT to maintain validated state of systemsIdentify, plan and outline responsibilities for validation efforts across GxP systemsProvide 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 requirementsHands on experience in authoring validation documents and associated procedures (SOPs)Strong interpersonal verbal and documentation skills 1424544_1753129344 To Apply for this Job Click Here