QA Operations Officer

Viatris; Dublin; On-site; EUR 60,000 - 75,000; Full time

Job summary

Viatris is seeking a QA Operations Officer in Ireland to strengthen manufacturing quality systems and ensure GMP compliance across processes. You will collaborate with manufacturing and engineering teams to monitor quality indicators and review batch records for release decisions.

The role requires a degree with 3+ years' experience, knowledge of EU/US regulations, and the ability to adapt to changing environments while maintaining attention to detail and strong cross-functional communication.

Qualifications

• Educated to degree level with 3+ years industry experience.
• Working knowledge of EU & US regulatory requirements.
• Experience in designing and implementing quality systems; startup experience is a plus.
• Knowledge of inhalation dosage forms is an advantage.
• Fluent in MS Word/Excel/PowerPoint; experienced with Trackwise and SAP.
• Strong teamwork and cross-functional communication.
• Ability to adapt in a changing environment and work under pressure.
• Attention to detail and priority management.

Responsibilities

• Collaborate with manufacturing and engineering to drive quality awareness and implement GMPs.
• Monitor key quality indicators in manufacturing to identify events and preventative measures.
• Review manufacturing batch records to support disposition of intermediate and final products.
• Assess deviations and changes with investigations and actions followed through.
• Ensure quality system continuity through Product Quality Reviews, self-inspections, and Quality Risk Management.

Skills

Quality systems

Communication

MS Office

Cross-functional

Attention to detail

Adaptability

Teamwork

Education

Bachelor's degree

Tools

Trackwise

SAP

Job description

McDermott Laboratories Limited Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. 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:

• 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.

The minimum qualifications for this role are:

• 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 when required.

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 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.

Viatris is an Equal Opportunity Employer.

Viatris is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, and Hyderabad, India.