c2c positions
Role: SAP Project Manager with Supply Chain Planning
Location : Foster City, CA (Hybrid)
Position type : Contract
Project Duration : Long Term
Experience : 15+ Years
Should know GxP, Validation and possibly MES
GxP Documentation is must
Need Global Biologics and SAP Supply Chain Planning experience.
Pharma/ Biotech/ Life Sciences/ Medical Device/ Healthcare or Pharma Manufacturing experience is a must ( Okay with either industry )
Detailed JD :
Need a Business Project Manager with good change management and Business Stakeholder Management experience.
Provide focused delivery of all aspects of project management, project scope definition, risk management, adaptable project scheduling, resource hiring and management
Change management and consistent project documentation and reporting.
Guide and direct implementation of infrastructure, systems, applications and technical integration activities.
Must be results oriented and ensure successful completion of the projects on time, on budget and within the defined scope while leading through influence and with solid soft skills and tact.
Project Management certified; PMP Change Management certified; (CCMP) will be preferred.
This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and 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 computer system validation and GAMP -5 standards.
To apply for this job email your details to lokesh@cloudthinktech.com