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Senior Qa Compliance Officer

Senior Qa Compliance Officer

1100 Mylan Pharmaceuticals Inc.Dublin, Ireland
7 days ago
Job description

Senior QA Compliance Officer page is loaded## Senior QA Compliance Officerlocations : Damastown, Dublin, Irelandtime type : Temps pleinposted on : Offre publiée hierjob requisition id : R5662521Rottapharm LimitedChez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être.

Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution.

Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie.

Via trois axes majeurs :

  • Accès
  • : En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.
  • Leadership
  • : En favorisant l'évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.
  • Partenariat
  • : En valorisant notre expertise collective afin de donner accès à tous à nos produits et services.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.

We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience.

Viatris is more than just a place to work.

This is a place to make a difference in the world.

  • The Role & What You Will Be Doing
  • Every day, we rise to the challenge to make a difference and here's how the Senior QA Compliance Officer role will make an impact :
  • Lead and manage the QA Compliance team, including setting objectives, performance management, training, and development.
  • Ensure effective oversight of compliance activities including complaints, change controls, deviations, CAPA, supplier management, APQR, PMSI, investigations, trend analysis, and document control.
  • Provide support for regulatory activities such as product variations, medical device updates, and procedural changes.
  • Monitor, analyze, and report on compliance-related quality metrics (daily, weekly, monthly, annually).
  • Manage QA Compliance team participation in internal, customer, and regulatory audits, ensuring inspection readiness at all times.
  • Participate in structured problem-solving activities such as RCA, risk assessments, HEP, and continuous improvement projects.
  • Drive engagement and promote a culture of quality and compliance in line with Viatris values and GMP standards.
  • Ensure departmental training compliance, supporting delivery of GMP training and tracking completion for team members.
  • Oversee housekeeping and adherence to 6-S principles to maintain a safe and compliant workplace.
  • Act as a point of escalation for compliance issues, providing timely resolution and ensuring adherence to regulatory timelines.
  • Deliver on cost and efficiency initiatives while maintaining a high standard of compliance across all QA systems.
  • About Your Skills & Experience
  • For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences :
  • Previous experience in Quality Assurance or Compliance within the pharmaceutical or medical device industry.
  • Bachelor's degree in a relevant discipline (Science, Engineering, or related field).
  • Proven expertise in quality systems including deviations, CAPA, complaints, APQR, audits, supplier management, and change management.
  • Strong working knowledge of cGMP, EU GMP Directives, and regulatory guidelines.
  • Hands-on experience with systems such as Trackwise, MES, SAP, LIMS.
  • Excellent problem-solving, analytical, and decision-making skills.
  • Strong ability to multitask and prioritize in a fast-paced environment.
  • Effective communicator with strong verbal and written skills.
  • Demonstrated ability to lead and develop teams, fostering engagement and accountability.
  • Proficient in MS Office applications (Word, Excel, PowerPoint)At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply.
  • You may just be the right candidate for this or other roles.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.

    You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

  • Diversity & Inclusion at Viatris
  • At Viatris, diversity and inclusion are essential to our mission.
  • The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be.

    If you would like to know more about what diversity, equity and inclusion means to us, please visit

  • Sustainability at Viatris
  • Corporate social responsibility is fundamental to the Viatris mission.
  • We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve.

    To learn more about our efforts, please visitChez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.locations : Damastown, Dublin, Irelandtime type : Temps pleinposted on : Offre publiée hierViatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer.

    En intégrant les atouts de ces deux entreprises, y compris notre main-d'œuvre mondiale d'environ 45 000 personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances.

    Nous croyons aux services de santé comme ils devraient l'être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie.

    Et parce que nous croyons fermement qu'un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d'excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin.

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    Compliance Officer • Dublin, Ireland