QA IT Lead -SME - cGxPServe : Job Details

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• Ensure IT processes and procedures meet Quality System requirements.
• Participate and support the Quality Risk Management (QRM) principles in risk assessment initiatives.
• Support the development, review, and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process.
• Collaborate with other functional areas to collect information and provide guidance throughout all stages of the quality management system and improvement projects.
• Ensure new systems, processes, and procedures are compliant with SOPs, WIs, data, and regulatory guidelines for IT and Software validation.
• Assist in resolving inspection management concerns related to software applications, procedures, and data integrity.

• Bachelor's degree in a relevant field (e.g., Life Science, Computer Science, Engineering, IT) preferred.
• At least 7 years of experience in Pharma manufacturing, Data Integrity, Deviations, GXP, IT QA Systems, validation, and related areas.
• This role is not for testing or validation specialists but for a SME supporting investigations, risk assessments, and IT operations post-validation.
• Extensive experience in an FDA-regulated environment with a focus on GxP compliance, risk-based validation, and data integrity.
• Strong knowledge of FDA CFRs, Eudralex, and biotech/pharma industry regulations related to IT and laboratory systems.
• Proficiency in SDLC validation methodology, software quality requirements, root cause analysis, and risk management techniques.
• Experience with quality management systems, including change control, incident, and deviation management.
• Strong project management skills, especially in systems validation across various areas such as laboratory, utilities, and manufacturing systems.