Computerised Systems Validation Specialist

Alphapharm Pty. Ltd.

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.

The CSV Specialist role will execute computerised system validation activities for both standalone and enterprise systems within the Production and Packaging departments. This includes providing technical expertise for Production and Packaging equipment and the support of new installations and the lifecycle management of existing equipment within these areas.

You will possess the following:

- a Bachelor's degree in technical science, IT or Engineering that has a focus on computerized systems
- Project Management experience (desirable)
- 5 years' experience within the Pharmaceutical Industry, IT or CSV (desirable)
- Previous experience in FDA and TGA regulated environments (desirable)
- A high degree of technical aptitude in automated manufacturing processes

**Responsibilities**:

- Execute computerised system activities (validation, training, and security)
- Support lifecycle management of standalone equipment and enterprise systems
- Provide and execute the validation requirements for new equipment/systems and upgrades to existing equipment/systems
- Assessment and support of new equipment/system purchases and installations
- Manage and execute computerised system projects
- Prepare and update validation documentation
- Provide technical guidance for computerised systems changes
- Provide support and guidance in collaboration activities with Global on computerised systems
- Support and encourage continuous improvement initiatives for the benefit of the Production and Packaging equipment and the wider business
- Ensure activities comply with cGMP, legal and ethical standards
- Plan, monitor and achieve goals within set time frames
- Provide, build and maintain consistent, reliable and accurate customer service
- Perform other duties as required by management
- Communicate and endorse safety practices, monitor key safety performance indicators and visibly participate in promoting safety policies and initiatives

Viatris Benefits:

- Employee rewards and discount platform
- Annual wellness allowance
- Recognition programs
- State of the art canteen onsite with a variety of subsidised food options
- Benefits for health and financial wellness
- Corporate deals with vendors including superannuation fund, health insurance and others
- Viatris Product loyalty program
- Free annual flu vaccination
- 2 days of paid volunteer leave per annum
- Additional paid parental leave
- Career and development planning for continuous growth and learning
- Retirement savings plans
- Annual leave loading, as well as paid additional bereavement leave

Culture

Viatris has been named in Forbes’ World’s Best Employers 2022 list. We have now received this recognition in each of our first two years - and for 2022, we are ranked in the top 10% of the 800 global employers who made the ranking.

Viatris strives to create a positive, productive work environment where integrity, dignity and mutual respect for all is ingrained each and every one of us.

Together, we are building a highly inclusive organization where employees are welcome to bring their best, authentic selves to work every day.

Our goal is to provide a safe, supportive community where employees feel they belong and can use their unique experiences, perspectives and skills to make a difference in 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.