18554-QA Specialist IT-Meath Contractor

This is an 11-month contract.

Purpose:

The Specialist Quality Assurance IT will be responsible for the quality aspects of GMP computerized systems and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations.

This includes involvement in quality-related activities for computerized systems which are required by the Company Quality Manual or with the potential for impact on product quality, patient safety, or data integrity.

The position will work closely with stakeholders and SMEs from site operations, quality operations, IT, automation, and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.

The Specialist QA IT must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

Responsibilities:

• As part of the global QA team and reporting to the Associate Director of QA Validation, the Specialist QA IT will be responsible for:
• Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner, and IT Owner) to assess and select computerized systems to support GMP business processes; to ensure technologies selected meet the high-level business needs; and ensure 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 with 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. This includes 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 the latest trends in validation and best practices.
•  Representing QA IT management upon request in the local site or system-specific meetings regarding computerized systems selection, operation, and/or compliance-related issues.
• Contribute 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.
• Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.

Requirements:

• Bachelor’s degree. Preferably Information Technology, Engineering, or equivalent.
• 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 an 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
• Business engagement skills, with ability to collaborate with both technical and non-technical roles
• Multi-lingual capabilities preferred
• Experience supporting regulatory inspections
• Excellent oral and written communication skills including persuading others and developing cross functional relationships
• Analytical problem solving skills applied to issue identification and resolution
• Listening, integrating diverse perspectives, adds value to the achievement of team goals
• Project management skills combined with a since of urgency and a proven history producing quality deliverables