Provide validation and documentation support for Manufacturing Execution Systems (MES) and Electronic Batch Records (eBRs) in a regulated pharmaceutical manufacturing environment.
Responsibilities
Develop, review, update, execute, and maintain computerized system validation documentation in accordance with GMP regulations and data integrity principles.
Support validation lifecycle documentation including URS, Functional Specifications, Design Specifications, Configuration Specifications, Risk Assessments, and Traceability Matrices.
Develop and execute IQ/OQ testing protocols and document validation results.
Coordinate activities with cross‑functional technical and business teams.
Prepare and review validation reports and summary reports.
Requirements
Bachelor’s degree in engineering, Computer Science, Information Technology, Life Sciences, Chemistry, or a related technical discipline
Nice to have: Syncade Enterprise MES (EMES)
Nice to have: Electronic batch record implementation
Senior Systems Analyst responsible for implementing, integrating, and optimizing digitization solutions within clinical-administrative transformation services.
Responsibilities
Participate in configuration and parameterization of digitization systems
Ensure ongoing maintenance, performance monitoring, and optimization
Analyze user needs and recommend innovative solutions
Ensure compliance with quality control and legal standards
Design and lead training sessions
Requirements
College Diploma (DEC) or university degree in a relevant field (Medical Archives, Clinical Informatics, or equivalent)
