What are the responsibilities and job description for the Project Manager position at RemasCompany Ltd?
About the Job
Project Manager
Seeking a Project Manager with experience in Pharma, Biotech, Life Sciences, Medical Device, Healthcare or Manufacturing. Industry experience is must.
Responsibilities:
- Lead and perform activities to create and maintain GxP quality and compliance environment for SAP S/4 HANA.
- Monitor Computer System validation (CSV) and GxP regulations including 21 CFR Part 11.
- Manage and/or maintain 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 test scripts for requirements and test scenario coverage.
- Lead protocol executions, log and track defects.
- Review executed test reports for proper documentation of test results and evidence.
- Review defects for proper documentation per checklist.
- Prepare and maintain traceability matrix to ensure all requirements are covered in design documents and tested.
- Prepare and approve qualification summary report.
- Participate in Corrective and Preventive Action (CAPA) and maintain quality metrics.
- Maintain project and issue tracker and report routinely.
- Support release management activities by reviewing pre-requisites prior to 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 team of validation engineers located in different time zones.
Requirements:
- 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 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.
