QA Compliance Engineer Data Integrity - 12 mth Fixed Terrm Contract
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Welcome to AbbVie!
At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond.
We are now recruiting a QA Compliance Engineer to join our diverse Quality team in Clonshaugh. QA Compliance Engineer role is a technical role that will primarily focus on the oversight of the program for electronic system compliance onsite.
This role is linked to the Quality Management System and Data Integrity program. The QA Compliance Engineer will work closely with IT, Operations, Maintenance, QA validation, QA Systems and the QC department to deliver and maintain compliance of the sites infrastructure information systems.
The QA Compliance Engineer will be responsible for and will be the site point of contact within the Quality Assurance department for liaising with owners of Global enterprise and Infrastructure systems.
The position incumbent is expected to adhere to all cGMP compliance and regulatory mandates and quality requirements and comply with all SOP’s and internal Allergan policies and procedures in the performance of job duties.
The QA Compliance Engineer applies skills and knowledge to recognize and resolve issues that impact efficiency, throughput, quality, and/or the fulfillment of the assigned performance targets.
The QA Compliance Engineer is responsible for the safe, compliant, and efficient execution of job duties in a team environment. This position reports directly to the QA Associate Director.
So let’s tell you a little more about this role…
• Manage and drive data integrity and data governance requirements for all Operational Information and Automation systems across the Business Unit incl. Operations, Laboratories, and QA systems
• Support the QA Data Integrity Specialist with ongoing data integrity remediation activities on the site Quality Improvement Plan
• Provide feedback to department owners on the status of data governance projects
• Support the Business Unit during audits from a data governance perspective.
• generation and routing of data mapping processes, risk assessments and criticality assessments in conjunction with QRM through the Quality Assurance process.
• generation and routing of data governance and system-based documents through the Quality Assurance process.
• Complete data governance reviews and subsequent remediation activities of business unit systems and processes.
• Generate data process maps to describe the data flows throughout the systems and to identify critical data control points/transactions.
• Identify data governance gaps and propose solutions
• Assist in data integrity investigations onsite As required, complete validation activities to ensure new and existing equipment/ systems and meet and maintain Annex 11, 21CFR Part 11 and GAMP5 requirements.
• partner with remediation activities including any potential validation activities to address identified process and/or equipment data governance gaps.
• Lead and/or assist the development of critical alarm matrix for systems which will lead into procedural controls.
• Develop training modules to continue the upskill and awareness of data governance across the business unit.
• Develop matrix of the systems access levels across users, set ups, administrators and engineers.
• Ensure security compliance for all Information and Automation systems
• Updating of the current system risk assessments and risk mitigation plans. Completion of risk assessments for new installs.
• Support personnel in effective audit trail reviews.
• Development and maintenance of site Quality agreements with Service providers from both intra company and external sources.
• Seek process innovation and continuous process improvement for IT management?
• Perform assigned task in accordance with procedural requirements and scheduled timelines. Notify supervisor and other impacted stakeholders if procedural requirements or timelines are not being met.
• Understand cGMPs and procedural requirements for your area of responsibility and be a resource to operators and other personnel to ensure compliance to these requirements.
• Assess and understand events that may not be in accordance with procedures or cGMPs. Make decisions consistent with job responsibilities, regulations and Allergan procedures and policies. Provide appropriate comments to cGMPs documents, when needed. Provide timely feedback and details to supervision and other impacted personnel.
• Complete and conform to all training requirements for job role, including company-required and job role-specific training.
• Carry out and assist in the on-going training of new and existing personnel, as appropriate.
• Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
• Minimum of Level 8 in Science, Engineering or Quality Qualification.
• Some exceptions made for those candidates demonstrating equivalent knowledge and having substantial pharmaceutical QA experience.
Technical Skills and Experience:
• Experience working in a relevant area within a manufacturing or GMP regulated environment
• Minimum of 3 years’ experience in a highly automated manufacturing environment
• Experience with a proven record of cross functional project delivery
• Systems background: ERP, MES, Data Historian (OSI PI), Chromatography (Empower) and laboratory management systems
• Proven experience working with qualification of data systems and quality investigation management
• Experience implementing governmental agency requirements in a cGMP regulated environment.
• Understanding of Quality Risk Management Metrics and the Lifecycle approach to Quality Systems
• Experience in using TrackWise, SAP, Microsoft Word, Excel and Outlook
• Knowledge of MS Windows system administration and system security
• Strong analytical skills and communication skills.
• Have the ability to make clear and courageous decisions
• Be able to influence key stakeholders at site and global level in the company
So, does this all sound like the right role for you? Then come join Abbvie!
AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.