Quality Assurance

1488 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.

Currently the Quality Assurance team is recruiting for a Quality Assurance - Authorised Person to join the team.

Key responsibilities for this role include:

- Release for supply of finished product manufactured for the Australian market, in accordance with the appropriate procedures, Marketing Authorizations and applicable regulatory guidelines (PIC/s Guide to GMP, TGA Guidance on Release for Supply)
- Release of bulk product and finished product to export markets in accordance with the appropriate procedures, Marketing Authorizations and applicable regulatory guidelines
- Ensure that all raw materials, packaging materials and bulk products are released in accordance with specifications and procedures
- Review of deviations (incidents and investigations), CAPA’s, Effectiveness Checks and complete trending for all deviations (incidents and investigations), raise Trend Assessments and attend the Trend Review Board meetings
- To ensure master batch manufacturing and packaging documents as well as SAP recipes are complete and correct and to approve these for use
- Support and encourage continuous improvement initiatives for the benefit of the Quality department and the wider business
- Provide support to manufacturing, packaging and maintenance regarding any queries relating to quality matters
- Approve Annual Product Quality Reviews
- Support and encourage continuous improvement initiatives for the benefit of the Quality department and the wider business
- Ensure activities comply with GMP, legal and ethical standards

The minimum qualifications for this role are:

- Tertiary qualification in Science or related field
- Minimum 5 years’ experience in the Pharmaceutical Industry
- Understanding of GMP and regulatory requirements
- Excellent communication and organization skills
- Experience with writing reports and presenting data
- Demonstrated attention to detail
- Proven ability to work under mínimal supervision
- Must be eligible to work in Australia (Australian Citizen or appropriate Visa holder)

Employee Benefits- Free onsite parking- Free fruit, tea, coffee and milo- Benefits for health and financial wellness- Annual leave loading, as well as paid bereavement leave- Additional paid parental leave- Retirement savings plans- Competitive compensation programs- Career and development planning for continuous growth and learning- Paid volunteer leave- Recognition programs

Culture- 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.