Central Employment are delighted to present an opportunity with our longstanding pharmaceutical business based in Cramlington. Due to a large increase in volumes they are looking for additional support in the Technology QA team. This is an excellent role with a top employer in the North East. The ideal candidate will have extensive GMP experience within computerised systems, or have worked in a highly regulated business within IT & Automation.
- The Specialist of Technology Quality Assurance 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 Quality Manual or with potential for impact on product quality, patient safety, or data integrity.
- The position will work closely with stakeholders and SME’s 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 of Technology Quality Assurance must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.
- Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and Technical 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 documentations 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.
- Driving resolution of regulatory non-conformance for GMP computerized systems.
- 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.
- Contribute to 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.
- 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.
- 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.
- 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.
This opportunity is for 6 – 12months with a strong possiblity of extension