Company: i-Pharm Consulting
Closing Date: 09 Dec 16
Salary (£): Negotiable
Quality Engineer (NPI) - Top Pharmaceutical Company Contract Quality Engineer required for leading Pharmaceutical Services Company. This role will supporting NPI projects with key focus around customer specification, validation master plan and protocols. You will provide the company with the technical, and quality resources to manage the quality deliverables on selected NPI projects. Candidates must be eligible to work in the EU. ...
Quality Engineer (NPI) - Top Pharmaceutical Company
Contract Quality Engineer required for leading Pharmaceutical Services Company. This role will supporting NPI projects with key focus around customer specification, validation master plan and protocols. You will provide the company with the technical, and quality resources to manage the quality deliverables on selected NPI projects. Candidates must be eligible to work in the EU.
Ireland / Dublin
- Review and approval of validation documentation
- Ensure the archiving and filing of validation documentation associated with the project
- Drive the close out of change control, deviations, quality continuous improvement identified during the project
- Analysing and reporting of key measures
- Drafting of the defect library and QSS during OQ
- Support internal and supplier audits
- Trending and tracking of quality data to drive improvements
- Facilitate equipment FMEA and ensure, with the Program Manager, that the SME is trained to the FMEA process and updated on the relevant FMEA
- Must have a third level qualification, at a minimum to degree level, in Engineering/Quality/Science
- Must have a minimum of 2 years’ post graduate experience of working in a high volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector
- A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential
- In-depth knowledge of validations in a Medical Device environment
- Strong IQ/OQ/PQ expertise with PPK and CPK, FMEA and Risk Assessment for relevant role
- An excellent understanding of plastic process manufacturing
- Good understanding of computer system validation
- Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab
- Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820
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 Recruitment Consultant Majella Byrne on +353 (0)1 513 5974, or email firstname.lastname@example.org. 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.
Quality Engineer / Tooling / Automation / NPI / Ireland / Republic of Ireland / Dublin / Validation / Minitab
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