Sr SQA Validation Lead

GxP Quality and Compliance Lead for SAP S/4 HANA

This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA.

This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11.

• Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system

• 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

• Review the test scripts for the requirements and test scenario coverage

• Lead overall protocol executions, log and track defects

• Review the executed test reports 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

• Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics

• Maintain overall project and issue tracker and report routinely

• 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

• Maintain day to day activities status tracker and report routinely

• Lead the team of validation engineers located in different time zones

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