Work Schedule
Environmental Conditions
Job Description
Determine and document user requirements for computer systems
Develop and implement software validation plans and protocols
Collaborate with diverse teams to ensure detailed execution of computer system validation activities.
Conduct risk assessments to identify potential issues and develop mitigation strategies
Perform data analysis and generate reports to support decision-making processes
Support with Deviations, CAPA, drafting and approving deviation logs and keeping artifacts audit ready in MasterControl, ALM and Service Now tools. A sound knowledge of SAP, EDMS/QMS systems like MasterControl, HP ALM, Documentum and CHG Management tool Service Now is preferred.
Review and draft standard operating procedures for tools refresh, upgrades, patching etc.
Coordinating with partners for configuration and design specs update and overall system CHG management.
Bachelor's degree in Computer Science or a related field, or equivalent experience.
Demonstrated expertise in computer system validation within the pharmaceutical industry
Strong analytical and problem-solving skills
Strong interpersonal skills for effective collaboration
Strong commitment to meeting regulatory requirements and industry standards