The Data Integrity (DI) and Computerised Systems (CS) specialist role has responsibility for the oversight and improvement of Quality and Compliance in all Data Management systems required to support the analytical and laboratory environment within the company.
The position is responsible for carrying out a diagnosis between current DI system and changes in the requirements of the authorities. Develop existing system plan by making an inventory of the potential gaps within the laboratory systems. Define mitigation actions for the identified gaps. Develop the short- and medium-term remediation plan. Driving improvements in data management and data integrity within the analytical and laboratory environment at the site in terms of culture of data integrity and will oversee the optimised implementation of all computerised systems. This position is responsible for monitoring and supporting the data management to all applicable GMP standards. The DI and CS Quality role may lead investigations, resolve potential quality issues, recommend and implement changes as necessary in order to mitigate risks associated with data integrity and data management.
This role will establish, manage and support continuous improvement activities of quality systems to ensure compliance, achievement of site goals / objectives and Inspection readiness. The DI and CS Quality role will implement analytical and laboratory Quality Improvement initiatives in Computerised Systems Utilisation, Data Management, Risk Management. This role will reduce and/or avoid significant Quality and Compliance site level risks in testing and release processes.
• Responsible for implementing the laboratory Data Integrity Strategy ensuring objectives are effectively achieved, consistent with site requirements to ensure compliance
• Lead Data Integrity (DI) activities within the analytical and laboratory environment for both computerised and non-computerised systems
• Provide Quality and cGMP input and oversight for all Data Management and Data Integrity activities
• Lead the laboratory in the compliance requirements of Data Management and Data Integrity
• Accountable for Quality oversight of processes and procedures related to DI, Computerised Systems & Automation compliance
• Develop, write, review and approve SOPs and controlled documents to support site DI / CSV activities and in accordance site procedures
• Ensure all associated systems are qualified in compliance with industry standards and regulatory expectations
• Provide quality expertise on validation activities performed during the qualification of any new analytical equipment
• Responsible for reviewing and supporting key CSV deliverables for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria
• Provide Quality direction, expertise and input at Change Control and Deviation Review
• Reviewing and assessing compliance of computerised systems including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up, and reporting/trending
• Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled
• Establish key objectives and metrics to support validation of GxP computer systems
• Prepare and present management updates on Data Management and Computerised Systems including how these systems improve performance at the site
• Interact professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems
• Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions
• Improve electronic capabilities in the analytical area
• Design and implementation of best practice quality improvement programs
• Thorough knowledge of cGMPs, GLPs, GDPs, Data Management and Data Integrity and Computer Systems Validation requirements. Knowledge of the QC lab process is also a key requirement.
• Ability to interpret and apply GLPs, GDP’s and GMPs for regulated systems validation
• Strong awareness and understanding of the pharma business, especially with regards to quality and regulatory requirements
• Demonstrated success in process improvement and sustaining change
• Ability to operate efficiently in a complex matrix organization and international environment
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