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QA Data Integrity Specialist

Job description

Quality Assurance Data Integrity Specialist

Job Responsibilities;

  • 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

Job Requirements;

  • 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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