My client a Cork based pharmaceutical company currently has a vacancy for a Quality Engineer
Key responsibilities will include the following:
- Supervision of Junior Quality personnel.
- Drive and implement process improvements to ensure predictable processes across all lines.
- Ensure all process variables and their interactions are adequately defined.
- Ensure all failure modes in process are identified & addressed. (e.g. Use of DOE studies, FMEA's).
- Drive and implement plant wide quality system improvements.
- Ensure Regulatory compliance in area of responsibility to cGMP's of all regulated agencies (e.g. FDA and TUV)
- Provide 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.
- Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
- Validation: Define process, product and test method validation requirements,
- Preparation and approval of Master Validation Plans and protocols.
- Compilation of required Regulatory documentation
- Educational Requirements:
- - Minimum qualification: BSC/BEng degree.
- - Minimum of 2/3 years experience in a QA role.
- - Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
- For more information please call Colin by E-Mail firstname.lastname@example.org