What are the responsibilities and job description for the Compliance Project Lead position at RemasCompany Ltd?
Responsibilities
This position is responsible for leading and performing activities in support of creating and maintaining GxP quality and compliance environment for SAP S/4 HANA.
Key responsibilities include:
- Leading the effort to manage, and/or maintain validation of SAP S/4 HANA system.
- Performing GxP and 21 CFR part 11 assessments and developing validation plan.
- Developing functional risk strategy and performing functional risk assessment.
- Reviewing user business process documents and user requirements specification.
- Reviewing functional, technical and configuration design documents.
- Preparing and/or reviewing Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols.
- Reviewing the test scripts for the requirements and test scenario coverage.
- Leading overall protocol executions, logging and tracking defects.
- Reviewing the executed test reports for the proper documentation of test results and evidence.
- Reviewing the defects for proper documentation per the checklist.
- Preparing and maintaining the traceability matrix to ensure all the requirements are covered in design documents and tested.
- Preparing and approving qualification summary report.
- Participating in Corrective and Preventive Action (CAPA), maintaining quality metrics.
- Maintaining overall project and issue tracker and reporting routinely.
- Supporting release management activities by reviewing and ensuring the pre-requisites are completed prior to the release.
- Reviewing Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials.
- Maintaining day to day activities status tracker and reporting routinely.
- Leading the team of validation engineers located in different time zones.
