QA Operations Officer

Viatris; Sutton; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Competitive salaries

Inclusive environment

Job summary

Viatris is seeking a QA Operations Officer to join our Dublin-area team. You will collaborate with manufacturing and engineering to uphold GMP standards, monitor quality indicators, and review batch records for disposition.

The role emphasizes deviations investigation, change control, and contributing to the Quality System to maintain product quality. Your background with EU/US regulations, quality systems, and experience with TrackWise or SAP will support ongoing stability and continuous

Qualifications

• Degree-level education with 3+ years industry experience.
• Experience designing quality systems and regulatory requirements.
• EU & US regulatory knowledge required.
• TrackWise/SAP experience beneficial.

Responsibilities

• Drive quality awareness with manufacturing and engineering to ensure GMP and continuous improvements.
• Monitor quality indicators in manufacturing to identify deviations and preventive actions.
• Review manufacturing batch records to assess disposition of intermediates and final product.
• Investigate deviations and changes and ensure corrective actions are implemented.
• Support Product Quality Reviews and self-inspections; apply Quality Risk Management.

Skills

Quality systems

Quality assurance

Regulatory knowledge

Attention to detail

Communication

Teamwork

Flexibility

Education

Bachelor’s degree

Tools

TrackWise

SAP

MS Project

MS Office

Excel

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.