GxP Validation Expert

Position: GxP Validation Expert

Location: Look for Local candidate in Richmond Virginia (23 Days in a week)

Must have skills : Quality leadership (Strong) SAP Activate Methodology (Capable) Testing concepts (Strong)

Job Description : GxP Validation Expert for an SAP S/4HANA implementation for a Pharma company in the US.

Responsibilities:

Identifies the applicable laws standards and best practices applicable to the project such as GAMP5 21 CFR Part 11 21 CFR Part 211 ICH Guidelines SAP Activate methodology.

Performs the GxP assessment and classifies the system.

Consults the Validation Lead and contributes to defining the Validation Plan and Validation Strategy in order to ensure compliance with regulatory requirements standards and best practices.

Provides input to and reviews the validation artefacts to ensure compliance (such as specifications risk and testing documents deployment and support plans training records etc.).

Key skills and experience:

Proven experience in the validation of SAP systems in the life sciences & healthcare industry (e.g. pharma MedTech).

Familiarity with business processes

Knowledge of the Computerised System Validation regulations and practices in the Life Sciences industry.