Quality Assurance Data Integrity Specialist
- Represent the site Quality Assurance department as SME in Data Integrity
- Co-ordinate Data Integrity activities for all systems for Manufacturing/ Laboratory/ IT areas.
- The QA Data integrity specialist will lead business process design efforts relating to Data Integrity solutions and chair the site Data Integrity council
- Track and provide Data Integrity metrics to Quality Management on a regular basis
- Manage the site Quality Risk Register and associated activities
- Perform Data Integrity risk assessment of all GMP documentation systems and support stakeholders in the mitigation of DI risks.
- Prioritize risks and work with all site departments to ensure documentation compliance
- Be current with regulatory requirements (FDA, HPRA) and possess a working knowledge of the documentation lifecycle Management in accordance with 21CFR Parts 210, 211, 11/ Annex 11, ICH Q9, Q10, GAMP5 and all applicable regulatory requirements
- Participate as Site DI SME on Veritas Project forums and working groups
- Ensure alignment between the local/ global data management and controls program efforts
- Represent Site in regulatory audits related to Data Integrity
- Establish a firm understanding of IT Infrastructure, assesses proposed changes for Data integrity implications, and recommends infrastructure changes to enhance Data Integrity
- Evaluate proposed/ existing software systems that support manufacturing, warehousing/ laboratory and software applications for Data Integrity gaps. Works with IT and QA to resolve those gaps
- Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines and fulfill requirements
- Write or review and approve protocols, reports and SOP’s to effect DI gap remediation as appropriate
- Initiate action reports or deviation reports for any applicable nonconformance
- Seek process innovation and continuous process improvements
- Recognize and report to supervisor any issues or deviations from accepted standards
- Provide status updates on own activities and productivity challenges according to defined procedures
- The QA Data Integrity Specialist will complete and conform to all training requirements for job role, including company-required and job role-specific training
- Carry out and assist in the ongoing training of new and existing personnel, as appropriate
- Observe all safety and compliance procedures and actively highlight any safety concerns
- The QA Data Integrity Specialist will have a BSc. In Science, Engineering or relevant discipline
- 5 years relevant experience in pharmaceutical, biotechnology or medical device industry
- Strong GMP knowledge.
- 3 years of experience in a computer systems validation (CSV) or quality assurance role with relevant CSV experience.
- Experience in technical and compliance requirements for validating IT systems in accordance with regulatory Data Integrity controls including 21CFR Parts 210, 211, 11/ Annex 11, ICH Q9, Q10, GAMP5 and all applicable regulatory requirements
- Excellent communication and interpersonal skills, including technical writing
- Strong analytical and problem-solving skills
- Computer literate; proficiency in using LIMS systems and Microsoft Office suite
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