- Collaborate with manufacturing, quality control, validation, 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 , QC testing processes to identify unexpected events and preventative measures in order to ensure continued product quality.
- Conduct checks and reviews of manufacturing , QC analytical testing, warehouse 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 and quality control 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. Review of Procedures (SOP's, Work Instructions, Validation related reports, etc.)
- Educated to degree level with 3+ years industry experience.
- Working knowledge of EU & US regulatory requirements.
- Experience in designing and implementing quality systems and/or a start-up an 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.
- Good team working and strong communication skills across functions and organization.
- An ability to work flexibly in a changing environment. Good attention to detail and priority management essential.
- Flexibility to learn new skills and take on new tasks and responsibilities.
- The ability to work under pressure to demanding schedules is important, as is the ability to work on one's own initiative.
- The ability to work different shift patterns.
QA Officer – Dublin Respiratory – 12 months agency contract - Baldoyle, Ireland - Viatris
Description
McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here's how the QA Operations Officer role will make an impact:
Key responsibilities for this role include:
The minimum qualifications for this role are:
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.