QA IT Specialist

Summary:

Our client is a global pharmaceutical company based in Meath looking for a Quality Assurance IT Specialist to join the team who will be responsible for the quality aspects of GMP computerized systems and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.

Responsibilities:

• Involvement in quality-related activities for computerized systems which are required by our client’s Quality Manual or with potential for impact on product quality, patient safety or data integrity.
• Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and our client’s IT Owner) to assess and select computerized systems to support GMP business processes.
• Ensuring technologies selected meet the high-level business needs and the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
• Providing the independent quality approval of key qualification /validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes /modifications /deviations /variances /compliance investigations).
• Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans).
• Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
• Supporting regulatory inspection and audit activities as needed including the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.
• Driving resolution of regulatory non-conformance for GMP computerized systems.
• Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.
• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
• Representing QA IT management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.
• Contributing in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems.

Qualifications & Experience:

• Bachelor’s degree, preferably Information Technology, Engineering or equivalent.
• Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
• At least two years of experience in delivering validated IT solutions or an application support role.
• Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations.
• Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation / compliance.
• Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
• Limited supervision required in day-to-day activities.
• Operate as part of a self-directed team in carrying out day to day functions and assigning priorities.
• Hands-on experience in a regulated pharmaceutical manufacturing and/or laboratory environment (Quality or Compliance role in GMP environment desired).
• Good understanding of applicable Laboratory and/ or Engineering Standards related to computerized systems development, implementation & Operations.
• Project management skills combined with a since of urgency and a proven history producing quality deliverables.