Site Self Inspection Lead

Site Self Inspection Lead page is loaded

Site Self Inspection LeadPostuler locations Damastown, Dublin, Ireland time type Temps plein posted on Offre publiée hier job requisition id R Rottapharm Limited

Chez 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

The Site Self-Inspection Lead ensures GMP compliance and inspection readiness at the manufacturing site. Key duties include leading self-inspections, conducting facility walk-throughs, managing the self-inspection program (scheduling, CAPAs, training), supporting regulatory inspection readiness, participating in global audits, and auditing third-party suppliers. This role acts as a key link between Site Leadership and Global Operations Auditing.

This position will work with a high level of independence and actively coordinate/participate in activities with Global functions across Viatris

Every day, we rise to the challenge to make a difference and here's how the Site Self Inspection Lead role will make an impact:

• Creation and tracking of the site self-inspection plan, inclusive of self-inspection scheduling and development of self-inspection agenda.

• Liaising with Site Leadership and Global Operations Auditing to gain alignment on selfinspection plan schedule and scope.

• Leading and participating in site self-inspections. Ensuring each self-inspection is appropriately recorded and communicated. Performing frequent unplanned and planned walk through inspections of the facility.

• Evaluation and tracking of CAPA items from self-inspections and providing guidance to site functions to ensure robust, holistic actions are developed. Ensuring that CAPAs are verified for effectiveness.

• Prepare annual trend reports for site self-inspection data and collaborate across Viatris to identify Global and/or regional opportunities. Facilitate bi-monthly reviews with site and global personnel to discuss site learnings and opportunities.

• Responsible for Site Audit Module and associated processes and procedures.

• Support overall site Inspection Readiness Plan, participating as required in site Board of Health inspections.

• Participate in Global Operations Audits of Viatris facilities.

• Perform external audits of third party suppliers as aligned with site and GOA requirements.

• Participate in global audit training and disseminate relevant detail to site teams. Provide training and coaching as required to broader site self-inspection team.

• Support any of the site quality culture initiatives, and perform other duties as required by management.

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:

• Minimum of a primary or higher degree in Science, Engineering, or related field with 10+ years' experience in GXP environments, including Quality Assurance.

• Strong understanding of cGMP and global regulatory requirements (FDA, WHO, EMA, ICH, ISO 9001), including Viatris policies and procedures.

• Proven leadership, accountability, and strong organizational skills; capable of working independently.

• Deep knowledge of quality systems and ability to apply global GMP standards to improve site systems and processes.

• Skilled in negotiation and collaboration with stakeholders at all levels, including senior leadership across Viatris

• Strong command of written and spoken English is essential. Local language as required for specific site is essential.

• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors to communicate ambiguous concepts. Ability to present to groups across the organization.

• audit qualification or training desired.

• Some travel expected. Potential for travel up to 20% of time.

• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems

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.

Why Viatris?

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 - and - Inclusion

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 visit - us/corporate - responsibility

Chez 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.

#J-18808-Ljbffr

---