Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
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Requirements:
- 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