Job Details for Quality Auditor
What you need to know
You will work as a Quality Auditor for our client in the pharmaceutical industry based in Carlow.
Reporting to the QA COE Lead, you will be responsible for reviewing core site Automation Compliance aspects of cGMP for operational areas of Vaccine Sterile and Pharmaceutical Operations, including site facilities, utilities, manufacturing, packaging, labelling, and laboratories.
Also responsible for compliance review, assessments, and conformance to Manufacturing Standards, MMD Quality Policies/Guidance for Automation System Development Life Cycle, and site procedures in accordance with regulatory regulations as related to the qualification, maintenance, auditing, and retirement of automated systems.
This is an 11-month contract position (some potential for extension but no guarantee).
Your new job
Key duties & responsibilities:
- Work on the coordination and execution of multiple independent projects.
- Provide guidance and technical skill knowledge to site relating to scientific area and/or automation SDLC and computer validation concepts.
- Maintain and support proactive communications regarding automation related activities to ensure conformance and maintain related work schedules.
- Facilitate and/or provide guided training and internal consulting services incorporating current industry practices and governmental regulations pertinent to automation qualification, compliance oversight, quality systems business ownership, and SDLC.
- Perform compliance oversight assessments and support regulatory inspections related to automation.
- Participate in activities to ensure audit/inspection readiness.
- Maintain project tracking systems and associated systems that support SDLC automation efforts, Quality Systems, and Compliance Systems.
- Comply with company global policies, procedures and guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Drive effective writing/revising/ rolling out of accurate operational procedures, processes, training documents and procedures for various Automation Compliance systems to support strategic automation initiatives, projects and compliance oversight initiatives; ensure all work is subsequently carried out in line with same.
- Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action through the change management system.
- Bachelors Degree or higher preferred; ideally in a Computer Science, Business Information Systems, Software Engineering or Automation/Process Control discipline
- Over 5 years’ experience in a manufacturing, preferably GMP setting
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Report, standards, policy writing skills required
- Knowledge of DeltaV, SAP and MES systems
- Proficiency in Microsoft Office and job related computer applications required
- Understanding of Lean Six Sigma Methodology preferred
- Deviation Management
- Knowledge of cGMP and GDP required
- Automation, IT and process validation required
- Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
- Demonstrable analytical and systematic problem solving skills
- Risk management and strategy development skills
Apply for this job now or get in touch with Rena on 01 4690901.
Matrix Recruitment Group is committed to providing a professional service where all CVs are kept confidential and will not be submitted to any clients without candidate’s knowledge or consent.