Computer System Validation/ Data Integrity Anaylst

Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems.

Computer system validation and Data Integrity are the core skills for this job.

Document review and helping the automation team to follow SDLC practices/DI practices

• Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and MMD IT Owner) to assess and select computerized systems to support GMP business processes; to ensure technologies selected meet the high-level business needs; and ensure the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
• Providing the independent quality approval of key qualification /validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations).
• Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans).
• Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
• Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.
• Driving resolution of regulatory non-conformance for GMP computerized systems.
• Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.
• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
• Representing DDQ management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.

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