A Quality Engineer on a 6 Month Fixed term Contract is required by CareerWise Recruitment for our Galway based client. This position will largely be responsible for reviewing & writing SOP's as well as ensuring the wider Quality Processes are in line with Regulatory requirements. Quality Assurance (QA) specialist is responsible for Quality in the areas of operations, production, and process and equipment systems. Responsibilities include full-cycle support for the assigned processes and vendors, and the willingness to become a subject matter expert (SME) with an in-depth understanding of the processes. Please contact Tom Devaney for more information.
Role of this position
- Quality Assurance oversight of operational activities, production, and validations and Technical Services projects to ensure QA systems and Manufacturing/Engineering systems have an independent assessment in order to remove any potential conflict of interest between ownership and administration.
- Writing and reviewing SOP's, Visual Standards and Guidance Documentation
- Ensuring Process and Equipment Validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits of our processes
- The following while serving as the QA representative on validation and technical services projects:
- Providing QA review and approval of site process and equipment validation documentation such as protocols, deviations and final reports.
- Providing QA support for change controls
- Managing and coordinating QA support during the execution of the project
- Serving as the QA liaison with all vested parties including QA/QC laboratories, IT, Manufacturing, and Engineering
- Serve as the QA representative on Validation and Technical Services projects.
- Serve as the Quality Assurance Review site process and equipment validation documentation representative and approver for protocols, deviations, and final reports.
- Managing and coordinating QA support of any Supplier Quality and Distribution Quality Issues and investigations.
- Management and oversight of Supplier Quality agreements.
- Supporting change control activities associated with processes and equipment validations.
- Managing and coordinating QA support for new and existing process equipment validation implementations.
- B.S.(level 8) Engineering, statistics or Sciences Degree from an accredited institution. Graduate Degree is preferred
- 5 x years relevant experience, working in areas such as Process Validations, Technology Transfer or Quality Engineering. A Masters degree may substitute for one years experience.
- Advanced user of Excel and Statistical programs such as Minitab.
- Experience in a GMP regulated environment preferred.
- Experience in an aseptic manufacturing environment preferred.
Please call Tom Devaney today for further information on 091-758771 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)