- Work Closely with R&D during the development and introduction of new products and technologies.
- Work with the R&D Team to ensure that all Quality Control Requirements for new products and technologies are defined and understood and that they are transferable and maintainable in a production environment.
- Lead failure analysis PFMEA, to ensure functional specification requirements are fully met during validation.
- Provide validation support by approval of validation documentation associated with new product validations and technologies.
- Technically understand the process in question and provide input to, development protocols, process validation protocols, inspections and analysis of results.
- Ensure agreement on acceptance criteria. Work with the Project Team to achieve a robust validated process that is in compliance with regulatory requirements and Global Requirements.
- Ensure that validation product is properly controlled, segregated and identified.
- Track, trend and report on Quality performance of new product introductions and technologies post validation.
- Drive the resolution, analysis and problem solving of new product related issues, working closely with both manufacturing Quality and R&D.
- Lead CAPA/Nonconformance activity when required.
- Ensure the efficient and timely transfer of Quality knowledge to manufacturing quality engineers and coordinate the training of quality engineers and quality technicians on new quality systems and equipment and products. Ensure all appropriate documentation is in place prior to production start.
- Ensure all cGMP are followed at all times and maintain good documentation protocol for work instructions, SOP’S and Forms
- Third level Qualifications in Science or Engineering
- Minimum 3-5 years’ experience in a regulated pharmaceutical/medical device with at least 2 years in a senior Quality Role essential.
- Full understanding and experience of the requirements of ISO 13485, 21 CFR Part 820 & Part 11.
- Understanding of data integrity requirements.
- Experience in providing Quality Support for Product Development and validation beneficial.
- Must have the ability to analyse and provide Quality Direction on product/equipment issues using independent judgement.
- Must be self-motivated, with ability to work on own initiative and prioritize.
- Must have the ability to motivate and influence people and drive corrective actions when necessary.
- Statistics/Six Sigma Qualification Beneficial.
- Must have good computer skills (Microsoft Office Products word processing, spreadsheets, data base, etc)
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email firstname.lastname@example.org