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:
1. Collaborate with manufacturing and engineering functions to drive quality awareness, facilitate Good Manufacturing Practices, and implement improvements to ensure product quality.
2. Implement and monitor key quality indicators within the manufacturing processes to identify unexpected events and preventative measures to ensure continued product quality.
3. Conduct checks and reviews of manufacturing operations to monitor factors that may affect product quality.
4. Review and evaluate all executed manufacturing batch records to facilitate the disposition of intermediate and final products.
5. Review and participate in all deviations and changes to manufacturing operations to ensure appropriate investigation, assessment, and implementation of actions.
6. Ensure continued product quality through the Quality System by:
* Review of Product Quality Reviews.
* Participation in self-inspections.
* Use of Quality Risk Management to ensure manufacturing operations are adequate.
* Review of results from ongoing stability studies.
Minimum qualifications for this role include:
* Educated to degree level with proven industry experience.
* Working knowledge of EU & US regulatory requirements.
* Experience in designing and implementing quality systems and/or a start-up experience is an advantage.
* Knowledge of inhalation dosage forms is 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.
* Ability to work flexibly in a changing environment, with good attention to detail and priority management.
* Willingness to learn new skills and take on new tasks and responsibilities.
* Ability to work under pressure to demanding schedules, independently, and on one's own initiative.
* Flexibility to work different shift patterns when required.
At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can utilize your experiences, perspectives, and skills to make an impact on the lives of others.
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