Digital Quality and Data Integrity, QA Consultant

Duties and Responsibilities: 

• Ensure GxP computer systems are designed, validated, and maintained in an appropriately risked based and compliant state throughout the entire systems and data lifecycles.
• Ensure GxP requirements are aligned with applicable regulatory requirements and internal procedures and Health Authority Regulations, including FDA, EU, MHRA, etc.
• Author plans, protocols, reports, test scripts, and SOPs supporting GxP computer system validation for clinical systems.
• Establish key objectives and metrics to support validation of GxP computer systems.
• Review technical/investigation reports as appropriate.
• Monitor, track and trend findings/corrective and preventive actions resulting from system audits. Support implementation of system CAPAs, Deviations and ensures timely closure.
• Review routine metrics and systems reports and facilities development of appropriate action plans as well as communication with key stakeholders.
• Perform other duties as required.

Project Deliverables:

• Successful Execution of GxP computer systems implementation following Agios procedures.
• Assurance of system requirements, aligned with applicable regulatory requirements and internal procedures and Health Authority Regulations, including FDA, EU, MHRA, etc.
• Delivery of plans, protocols, reports, test scripts, and SOPs supporting GxP computer system validation for clinical systems.

Capabilities:

• Prior experience of validating and working with Clinical Data Management Systems like Medidata, Pinnacle 21, Clinical Pipe, Spotfire, etc. preferred
• Strong knowledge of GCP, GAMP, technical writing principles and quality systems.
• Strong knowledge of IT compliance SOPs including change control practices/strategies, and system risk assessments.

Skills Required:

• 12 years of Computer System Validation experience in a GxP pharmaceutical environment.
• Working knowledge of quality systems and regulatory requirements (21 CFR Part 11, 210, 211,58, 820, ICH 8, ICH 9, ICH 10, Annex 11, etc.).
• Data integrity guidance (e.g., FDA, MHRA, CFDA, etc.).
• Proficient in MS Word, Excel, Power Point and other applications.
• Excellent written and verbal communication skills.
• Analytical thought leader with strong ability to analyze systems, data, validation plans and reports to identify creative solutions to appropriately mitigate technical risks.
• Skilled presenter with ability to convey technical information to an audience at all levels within the organization.