Validation Expert with S4 Hana - San Francisco, United States - Ampcus Incorporated

Ampcus Incorporated

Verified Company

San Francisco, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Role:
Validation Expert with S4 HANA

Location:
California (Bay area)

Expertise:
Validation Expert with S4 HANA

Duration: 1 year

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

Skills:

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

Excellent knowledge of computer system validation and GAMP -5 standards