Clinical Quality Validation Consultant

Clinical Quality Validation Consultant

Description:

Hybrid – must be a local (Nutley) candidate willing to come on site at least 2 days a week, with one of them being Wednesday (more, if needed).

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 Eisai’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