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