Authorised Person

Ipswich, QLD
Permanent
Full-time

8 days ago

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 our Quality Assurance department is seeking an Authorised Person to join the team at our Carole Park site.Key responsibilities of the Authorised Person 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

To be considered for the Authorised Person role, candidates should have:

Tertiary qualification in Science or related field
Minimum 5 years’ experience in the Pharmaceutical Industry (desired)
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 minimal supervision
Must be eligible to work in Australia (Australian Citizen or appropriate Visa holder)

About You

Problem solving skills
Neat handwriting
Initiative and a "can-do" attitude
Experience in a similar environment (preferred)
Ability to read and follow instructions
Ability to Calculate and solve mathematical problems using a calculator
Ability to Interpret and plot numbers on charts
Ability to Understand the importance of strict, government enforced procedures

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

CultureViatris 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.

Viatris

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