Regulatory Quality Compliance Officer

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 Systems department is seeking a Regulatory Quality Compliance Officer to join the team. The Regulatory Quality Compliance Officer is responsible to coordinate changes to products, equipment, systems or facility through Change Management Systems, among other duties noted below.

Key Duties and Responsibilities:

- Maintain current and comprehensive change control records
- Ensure compliance with local/national regulations, cGMP and applicable current compendia
- Manage, progress and submit projects and change controls through to closure in accordance with departmental and business goals
- Document, coordinate and provide quality oversight for projects and change controls ensuring appropriate action plans are in place to maintain regulatory and quality compliance
- Support the review, creation, update and issuance of Master documents to ensure compliance with GxP, regulatory and quality requirements
- Support and encourage continuous improvement initiatives for the benefit of the Quality department and the wider business
- Ensure activities comply with GxP, legal and ethical standards
- Plan, monitor and achieve goals within set time frames

Key Criteria:

- Qualifications in Science or related;
- High aptitude for Microsoft Word and Excel Programs;
- Strong Good Documentation practices;
- Attention to detail;
- Excellent communication and organisation skills;
- Ability to establish and maintain relationships with peers, business contacts, and corporate management;
- Ability to effectively manage time and meet deadlines and targets with competing and conflicting priorities under mínimal supervision;
- Ability to follow prescribed and detailed procedures to comply with GxP;
- Previous experience working within an Electronic Document Management System is desirable;
- Previous regulatory experience is desirable but not mandatory;
- Previous experience in a GMP Environment is desirable.

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.