Quality and Compliance Coordinator

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.

Join our Operations team at our pharmaceutical manufacturing plant in Carole Park

To support Operations in the achievement of compliance goals working within the site Quality Management System (QMS) to complete deviations, complaints, equipment periodic reviews and other quality and compliance activities. Coach Operations staff in the successful completion of their quality and compliance activities and deliver improvements in Operations quality and compliance performance.

Main Duties
- Provide guidance, training, and support to the Operations Department in the areas of deviations - root cause analysis, report writing, Corrective and Preventive Action (CAPA), trend assessments, and any other assigned compliance records or activities.
- Write factual, clear, and well-structured reports that describe and analyse a situation, trend or problem, making recommendations for future corrective and preventative actions.
- Ensure priority queries/tasks are on track and complete by due dates.
- All compliance records (incidents, investigations, Corrective and Preventive Actions (CAPAs), change controls etc.) under your responsibility to be completed on time and in an effective manner.
- Use of computerised tools to generate data and KPIs (Excel, Minitab, SAP, LIMS)
- Ensure cGMP compliance by following company policies and procedures
- Complete cGMP documentation to cGMP standards
- Report any deviations in processing or procedures immediately
- Identify and participate in the implementation of Continuous Improvement opportunities and projects with a focus on quality and compliance
- Participate in Operational Excellence workshops and training
- Positively contribute to a motivated and engaged workforce through effective communication, participation and teamwork
- Manage your work efficiently and cost effectively to meet Operations plans and targets
- Maintain the required level of skill and competencies relevant for your job role and development
- Promote a safe and healthy workplace by complying with company instructions and processes, taking reasonable care to ensure your own safety and health and that of others, and to report any injury, hazard or illness immediately.
- Other duties as requested by your manager

About you
- A minimum of 3 years of GMP experience
- Preferred experience in the pharmaceutical industry
- Previous lean management experience preferred
- Bachelor’s degree

Employee Benefits
- Free onsite parking
- Recognition programs
- State of the art canteen onsite with a variety of subsidised food options
- 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
- Free fruit, tea, coffee and milo
- Various lunchroom and washroom facilities around the site
- Career and development planning for continuous growth and learning
- Paid volunteer 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.