Company: i-Pharm Consulting
Closing Date: 25 Jan 17
Salary (£): Negotiable
Senior Quality Engineer (NPI) / Dublin Dublin based client is looking for a Senior Quality Engineer. The candidate will be responsible for reporting on project progress, identifying successes, driving compliance via validation master plan (VMP) / customer specification. Escalate to the Program Manager / Quality & Regulatory Manager as required. Responsible for the introduction of quality requirements of new or transferred products into company. ...
Senior Quality Engineer (NPI) / Dublin
Dublin based client is looking for a Senior Quality Engineer. The candidate will be responsible for reporting on project progress, identifying successes, driving compliance via validation master plan (VMP) / customer specification. Escalate to the Program Manager / Quality & Regulatory Manager as required. Responsible for the introduction of quality requirements of new or transferred products into company.
Senior Quality Engineer / NPI
Ireland / Leinster / Dublin
Permanent / Excellent Salary / Generous Benefits
KEY DUTIES & RESPONSIBILITIES
• Responsible for the generation of a Risk Management Plan (RMP) for the project covering quality, supplier chain, timeline and commercial risks.
• Facilitate equipment failure, mode and effects analysis (FMEA) and ensure with the Program Manager that the subject matter expert (SME) is trained to and updated the relevant FMEA as required
• Generation of the VMP and defining the documentation path the project will take
• Review and approval of validation documentation (protocols & reports)as a compliance review against the signed off VMP and customer requirements
• Support the initiation and completion of the QFD (Quality Function Deployment) in a timely manager
• Support timely analysis of metrology data at the various stages
• Drive the close out of change control, deviations, quality continuous improvement identified during the project.
• Compliance to all local site company policies, procedures and corporate policies.
• Lead and manage a high performing team to deliver the defined business goals and objectives.
• Act in accordance with the company’s guiding principles and adherence to the corporate Code of Conduct.
• Must have a third level qualification in Engineering/Quality/Science with minimum of 5 years’ experience of working in a high volume manufacturing environment ideally in the medical device / pharmaceutical sector.
• Must have an in-depth knowledge of validations in a medical device environment.
• An excellent understanding of plastic process manufacturing, computer validation, analytical methods and testing and documentation systems
• Must have a thorough understanding of statistics, SPC, and ideally the use of minitab.
• Must have excellent communication skills both oral and written,be able to prioritize and organise tasks.
• Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred. Auditing experience to 21 Part 820 and / or 21 Part 211 is considered an advantage.
• A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential. Knowledge of 21 CFR Part 210 / 211 would be considered an advantage
ABOUT i-PHARM CONSULTING
i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
If you would like to discuss this vacancy further, please call Principal Consultant Majella Byrne on +353 (0)1 5135974 If this role is not suitable, Majella is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
Validation Engineer / Senior Quality Engineer / QA Engineer / NPI / Ireland / Dublin / GMP / Good Manufacturing Practices / Pharmaceutical / Global Pharma / Medical Devices
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