QA Operations Officer (12 Months Agency Contract)

Viatris; Ireland; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Viatris is seeking a QA Operations Officer to ensure product quality across manufacturing processes. You will collaborate with manufacturing and engineering to drive GMP best practices and monitor quality indicators, supporting batch release and investigations.

The role requires a degree and 3+ years’ experience with regulatory knowledge and quality systems. Proficiency in TrackWise, SAP, and MS Office is advantageous.

Qualifications

• Educated to degree level with 3+ years industry experience.
• Experience in designing and implementing quality systems and/or a start-up an advantage.
• Working knowledge of EU & US regulatory requirements.
• Experience in inhalation dosage forms an advantage.
• Proficiency in documentation/databases such as TrackWise, SAP, etc.

Responsibilities

• Collaborate with manufacturing and engineering to drive quality awareness and GMP improvements.
• Monitor key quality indicators within manufacturing processes to identify events and preventative actions.
• Review manufacturing batch records to facilitate disposition of intermediate and final products.
• Evaluate deviations and changes to ensure investigations and actions are carried out.
• Support Product Quality Reviews and participate in self-inspections.

Skills

Quality systems

Regulatory knowledge

Communication

MS Office

SQL/Documentation systems

Education

Bachelor's degree in a relevant field

Tools

SAP

TrackWise

MS Excel

MS Word

MS PowerPoint

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.

Benefits and Compensation

• 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.
• A t Viatris, we offer competitive salar ies , 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.