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.

Job Description & Qualifications

Currently our Quality Systems department is seeking a Regulatory Quality Compliance Officer to join the team for a contract until the end of 2025. 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 with change controls is highly desirable;
- Previous regulatory experience is desirable but not mandatory;
- Previous experience in a GMP Environment is desirable.

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 plann