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. 
 

The Site Self-Inspection Manager is a critical role based at our Carole Park facility, to collaborate between our Global Operations Auditing team and Site Leadership team, providing key regulatory GMP knowledge, performing activities to support site inspection readiness and maintenance of site compliance.

Key responsibilities for this role include:

Leading and participating in site self-inspections. Ensuring each self-inspection is appropriately recorded and communicated. Performing frequent unplanned and planned walk-through inspections of the facility.Managing the self-inspection program, inclusive of scheduling, tracking, CAPA development and effectiveness verification, coaching and training of other self-inspectors.Creation and tracking of the site self-inspection plan, inclusive of self-inspection scheduling and development of self-inspection agenda.Supporting overall site Inspection Readiness Plan, participating as required in site Board of Health inspections.Liaising with Site Leadership and Global Operations Auditing to gain alignment on self-inspection plan schedule and scope.Evaluation and tracking of CAPA items from self-inspections and providing guidance to site functions to ensure robust, holistic actions are developed.  Ensuring that CAPAs are verified for effectiveness.Prepare annual trend reports for site self-inspection data and collaborate across Viatris to identify Global and/or regional opportunities. Facilitate bi-monthly reviews with site and global personnel to discuss site learnings and opportunities.Participate in Global Operations Audits of Viatris facilities.Perform external audits of third-party suppliers as aligned with site and GOA requirements.Participate in global audit training and disseminate relevant detail to site teams. Provide training and coaching as required to broader site self-inspection team.Follow and apply company policies and objectives, SOPs, GMP and health and safety requirementsPotential for up to 20% travel, although primary focus will be at site/Carole Park.

To be considered for the Site Self-Inspection Manager role, candidates should possess:

Tertiary qualifications in Science, Pharmacy/ Pharmaceutical sciences, Engineering or related discipline.Significant experience in GxP settings, extending across a range of functions inclusive of Quality Assurance.Audit qualification or training desired but not essential.Extensive understanding of pharmaceutical cGMP and global and local regulations, including but not limited to TGA, US FDA, WHO, EMA, ICH and ISO 900.Knowledge of Quality Systems requirements, including ability to evaluate and apply GMP to support enhancement to site systems and processes.Demonstrated personal leadership, accountability, and organizational skills with proven ability to operate independently with minimal supervision.Ability to read and interpret complex business and/or technical documents.Ability to write comprehensive reports and detailed business correspondence. Comprehensive and demonstrated written and verbal communication skills are required.Demonstrated ability to negotiate and collaborate with individuals and groups at multiple levels across the organization including senior leadership of various functional lines across Viatris.

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.