Computer System Validation cum Business Analyst #SGUnitedTraineeships

This position will report to IT Senior Manager for SEATW and interfaces with multiple business functional teams. Thermofisher Scientific is committed to an employee-orientated, high performance culture that emphasises empowerment, quality, continuous improvement, and the recruitment and on-going development of a superior workplace.

Specific Responsibilities

• Assist Project team to migrate MES Promis to MES Camstar by end 2021.
• Build dashboard and reports.
• Transform business requirements in to MES solutions by configuration or by working with local project team and development teams over MES enhancements.
• Manage (Review, Test and Release) on MES Camstar release cycle.
• Modeling of Product, BOM, Workflow routing, electronic procedures, labels, etc
• Guide business users over MES modeling, operating procedures and enquiries.
• Document & train end users for proper usage of MES.
• Attending and resolve issues raised by users

• Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution with good understanding of 21 CFR Part 11, FDA (GxP) regulations, and GAMP methodologies.

• Coordinate with multi-disciplinary validation team and be responsible for the validation of Camstar.

• Assist or coordinate the generation of Standard Operating Procedures (SOPs), create and modify, but not limited to the following documents:-

• User Requirements Specifications (URS)
• Design Reviews (DR)
• Criticality assessment
• CSV protocols (IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements
• Reports which summarize the results of the protocol executions

Exception reports which identify defects or issues during test execution

Technical Skills and Competencies:

• Degree major in Engineering or Science discipline. Preferably in Computer Science/Information Technology.

• Minimum 3 years of experience in Pharmaceutical Industry
• Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with different level of stakeholders
• Gathering and documenting requirements, process mapping skills Experience with MES and IT operation is desirable
• Familiar with IT Software development life cycle.

• Experience with Quality Change Control is desirable

• Familiar with compliance requirements (FDA, GxP, GAMP 5, 21 CFR Part 11)