Currently seeking an experienced Quality Engineer who is ready to take on a challenge in a globally leading medical devices company.
- Reviewing and writing reports, procedures and validation documents in support of establishing pharmaceutical quality system to GMP requirements.
- Subject Matter Expert regarding Acceptable Quality Standards and GMP practices for products and processes.
- Providing effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
- Evaluating quality events ensuring compliance with cGMP and quality standard requirements.
- Supporting root cause analysis, product impact assessments and corrective and preventative actions (CAPAs) for quality events.
- Ensuring all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed.
- Ensuring Regulatory compliance in area of responsibility for GMP pharmaceutical regulatory agencies (FDA, HPRA etc.)
- Providing functional expertise to other support functions on quality related issues.
- Identification and implementation of appropriate statistical techniques to monitor process performance.
- Approval of change requests for product, process and quality system changes.
- Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- MRB: Review of MRB trends and identification of appropriate corrective actions when required.
- Supporting the implementation of Lean Manufacturing across the site.
- 2-5 years’ experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
- Previous experience in a Quality, or Manufacturing background, particularly in relation to pharmaceutical quality systems
- Experience in the pharmaceutical industry and GMP manufacturing
- Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry quality requirements and associated with manufacturing controls.
- Experience in problem solving and process improvement methodologies
- Process Validation, Risk Management, CAPA experience.
- Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
- Strong command of MS Office – Word, Excel, PowerPoint.
For a confidential discussion on this or any other job opportunities please contact Jakub on 021 2359 140 / firstname.lastname@example.org
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