SAP S/4 HANA Validation/Gxp Expert

Greetings from IT Engagements…!

IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients.

Role: SAP S/4 HANA Validation Expert

Location: 100% onsite in California (Bay area)

Start: Immediate

Duration: 1 year

USC and GC works only - Range starts at $60

Please note: S4Hana experience is a MUST

Job Requirements:

• Support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA Perform GxP and 21 CFR part 11 assessments and develop validation plan
• Develop functional risk strategy and perform functional risk assessment
• Review user business process documents and user requirements specification
• Review functional, technical and configuration design documents
• Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols
• Draft the OQ & PQ test scripts for the GxP requirements and E2E GxP test scenarios
• Support overall protocol executions, log and track defects
• Review the executed test protocols for the proper documentation of test results and evidence
• Review the defects for proper documentation per the checklist
• Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested
• Prepare and approve qualification summary report
• Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release
• Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials

Required Skills:

• Must have Computer system Validation experience in the Life Sciences Industry
• Excellent communication (oral and written) and attention to detail
• 8 years in Computer System Validation in Life Science domain with minimum 3 years of experience in managing large global SAP validation projects
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
• Excellent knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11 (MUST HAVE)
• Excellent knowledge of computer system validation and GAMP -5 standards

Regards,

Shashank Jaitly

Shashank@itengagements.com

Job Type: Contract

Pay: $43.84 - $70.00 per hour

Experience level:

• 8 years

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• SAP: 8 years (Preferred)
• SAP S/4HANA: 8 years (Preferred)
• GxP regulations: 5 years (Preferred)
• 21 CFR Part 11: 4 years (Preferred)
• EMEA guidelines: 4 years (Preferred)

Work Location: In person