HOW MIGHT YOU DEFY IMAGINATION?

Let’s do this. Let’s change the world.

If you feel like you are part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us!

Live

What you will do

The key areas of focus for this Quality role are to ensure compliance with Australian code of Good Manufacturing Practices (GMPs)/Good Distribution Practice (GDP) and support of the complaint management process for Amgen products.

As part of a close-knit team, reporting to the Senior Manager Quality Assurance AU/NZ, the role offers broad involvement across Quality activities, including:

• Responsibility for the release for distribution in accordance with cGMP of all Amgen commercial products

• Inspect and accept incoming commercial shipments as per cGMP, GDP and SOP’s

• Manage any incidents relating to product quality including temperature excursions and report to management on trends

• Support the customer complaint process by ensuring all quality complaints are evaluated and investigated within company policy and regulatory timeframe expectations.  Report to management and marketing on volumes and trends

• Liaise and provide input to Supply Chain Manager on issues or customer complaints pertaining to supply or distribution

• Write/review/approve local and global documentation in accordance with relevant regulatory requirements and company policy ensuring specifically that Australian compliance and management requirements are included

• Assist with the design and delivering of training to internal staff and 3rd party contractors on compliance activities for drug products and medical devices

• Participate in audits of contract distribution/manufacturing facilities in Australia, including assisting with the preparation and close out of audit reports

• Provide support with quality assurance activities to the Asia regions as required

• Develop a working knowledge and understanding of key areas of the biological product industry including manufacturing/quality testing and relevant legislation/guidelines through on the job experience and by attending applicable courses, seminars, meetings etc.

• Be aware of and work within company and industry policies (Medicines Australia

• Perform other functions and duties that may be assigned

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The person we seek is a collaborative, communicative, tech-savvy and innovative individual with these attributes/qualifications:

• Tertiary qualifications in Health Sciences or related field

• Proven track record in a Quality related role within the pharmaceutical industry

• Experience in GMP auditing and training desirable

• Work effectively in team/matrix environment on multiple projects

• Demonstrated ability to anticipate and resolve problems

• Experience in Manufacturing/Logistics/Supply Chain an advantage

• Knowledge of the international codes of GMP, GDP, and related international and TGA/Medsafe guidelines

• Knowledge of ISO 9000 Quality Management Systems

• Auditing methodology desirable

• Validation methodology desirable

• Proven ability to understand technical, scientific and medical information

• Proficient with computer software; including Word, Excel, PowerPoint, Network environment, SAP

• Fluency in English, strong verbal and written communication

• Work rights and residency in Australia required

We are looking for a collaborative, results-focused team player who is positive, calm under pressure with strong attention to detail. A persistent, motivated individual with the ability to problem-solve, work autonomously and take accountability for outcomes will be a great fit for our team.

Thrive

Some of the rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional, personal growth and well-being.

• Extensive opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Amgen Australia are focused on inspiring talent to directly connect with our brand; today and tomorrow.  We respectfully request agencies do not submit unsolicited resumes and candidates are encouraged to always apply directly.

Applications Close Friday 19th March 2021, but candidates are encouraged to apply asap - interviews will commence on receipt of application.