Validation Manager

Posted:
11/11/2024, 4:00:00 PM

Location(s):
Conamara Municipal District, Ireland

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
Product

Mylan Teoranta

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via: 

Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
Partnership – Leveraging our collective expertise to connect people to products and 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

Provide overall leadership for validation activities, supporting the site in ensuring that all equipment and facilities are kept in state of validation as per validation plan and regulatory compliance. Position is to ensure that the validation function is operating within budget and continually improve efficiencies.  Supporting inspections and audits.  Additionally ensure timely execution of capital investments project

The Validation Manager will be responsible for ensuring  the validation program, as developed and executed as per site needs and in consultation with Manufacturing operations and Engineering functions, at Mylan Teoranta, a Viatris Company is compliant with various regulatory guidelines and assures products and processes conform to established validation and qualification requirements and standards through appropriate team involvement and test activities.

Every day, we rise to the challenge to make a difference and here’s how the Validation Manager role will make an impact:

  • The incumbent has experience in managing highly regulated  Sterile Pharmaceutical site(s). He has extensive knowledge in Sterile Manufacturing processes, Equipment and facilities. Has experience in executing capital project executions, new product introductions, technology transfer and understanding of new technologies.

  • Strategizing and implementing the validation master plan and budgets in sync with business needs.  Ensure the site have the right resources and capabilities to deliver the business objectives.

  • Planning and execution of new products and new equipment projects within budget, scope and timelines.

  • Manage all equipment, utility, process. As the facility is a sterile facility candidate must have mastered in handling validation of Sterilizer Tunnel/Autoclave, Lyophilizer, Smoke Studies, cRab, Isolators, Media fill and all other sterile/Packaging activities on site.

  • Ensure all validation exercises are being executed in a manner compliant with regulatory guidelines.

  • Provide documented support as required for regulatory submissions.

  • Write, review and approve SOPs, protocols, reports and other documentation as required.

  • Manage and develop direct reports, including setting objectives, mentoring and performance management.

  • Manage the departmental budget.

  • Promote a culture of continuous improvement in the Validation Department

Key Performance Indicator

  • No Critical/major observations related to qualifications in regulated audits.

  • Key Project Deliverables (qualification part) as per agreed timelines, quality and budget.

  • Demonstrated productivity improvement and pipeline of continuous improvement ideas.

  • Perform other duties as assigned. Including current regulatory trends, regulatory actions, guidance’s and accordingly prepare a gap assessments and compliance actions of the organization and prepare and implement compliance action reports in consultation with QA post regulatory/global/other audits.

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 Bachelor’s Degree in a Pharmacy/Science, Production or Process discipline and a minimum of 12+ years’ experience in a Pharmaceutical Sterile area Validation  with leadership experience.

  • Project Management Certified (would be an advantage).

  • However, a combination of experience and/or education will be taken into consideration.  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.

  • Must possess and demonstrate excellent communication skills (verbal and written).

  • Must have proven people leadership/management skills.

  • Shall have the ability to create subject matter experts on various subjects or type of technology

  • Ability to lead and coach project teams

  • A team player with capability to work across boundaries, and geographies.  Collaboration and highly committed

  • Must be highly organized, productive and quality oriented with excellent attention to detail

  • Position directly supervises a no. of colleagues who are expert in their validation discipline.  Carry out leadership

  • responsibilities in accordance with the organization's policies and applicable laws.  Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems .As this position is also required to provide technical leadership therefore the person has to technically competent.

Benefits at 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. Some of our benefits include the following on top of a competitive salary:

  • Excellent career progression opportunities

  • Work-life balance initiatives

  • Bonus scheme

  • Health insurance

  • Pension

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 https://www.viatris.com/en/Careers/Diversity-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 https://www.viatris.com/en/about-us/corporate-responsibility

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.