Description
A global generic pharmaceutical company are looking for a Quality Operations Specialist to join their manufacturing team.Day to Day:
- Collaborate with manufacturing and engineering functions to drive quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure product quality.
- Implement and monitor key quality indicators within the manufacturing processes to identify unexpected events and preventative measures in order to ensure continued product quality.
- Conduct checks and reviews of manufacturing operations to monitor factors which may affect product quality.
- Review and evaluate all executed manufacturing batch records to facilitate disposition of intermediate product and final product Batch release.
- Review and participate in all deviations and changes to manufacturing operations to ensure appropriate investigation and assessment is carried out and actions implemented and monitored.
- Ensure continued product quality through the Quality System by:
- Preparation and review of Product Quality Reviews.
- Participate in self inspections.
- Use of Quality Risk Management to ensure manufacturing operations are adequate.
- Review of results from on-going stability studies.
Requirements:
- Educated to degree level with 3+ years industry experience.
- Strong working knowledge of EU & US regulatory requirements.
- Experience in designing and implementing quality systems and/or a start-up a distinct advantage.
- Experience in or knowledge of inhalation dosage forms an advantage.
- High proficiency in Microsoft Word/Excel/Powerpoint/MS Project etc.
- Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc.
If you are interested in this great opportunity and have the appropriate skill set and experience please contact me Anna Mooney or apply below with an up to date CV.