Position: GxP Validation Expert
Job Location: Reston, VA (Hybrid)
Job Type: W2 Contract (12+ Months)
Job Description
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.
Job Type: Full-time
Pay: $50.00 - $60.00 per hour
Benefits:
- Employee discount
- Life insurance
- Referral program
Schedule:
Work setting:
Experience:
- Manufacturing: 1 year (Preferred)
Shift availability:
Ability to Commute:
- Reston, VA 20191 (Required)
Work Location: In person