Address
SalaryTogether, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
This role manages quality for Teva in ANZ. The person will be responsible for all the Commercial QA activities of Australia and New Zealand for Teva products, including but not limited to Branded, Specialty, Generics, Branded Generics, Biosimilars and medical devices.
How you'll spend your day
- Responsible for quality oversight and regulatory compliance of products marketed in the country.
- Responsible for quality approval and management of local 3rd party supplies and manufacturers.
- Teva Quality Management system: Create, maintain up-to-date and distribute Standard Operating Procedures and working Instructions as per Teva standard and in compliance with normal regulations and Ensure GMP & GDP compliance at the commercial unit and promote the quality culture.
- Operational implementation of Quality Management System.
- Market release: Ensure the market release from approved suppliers based on batch release documentation and transport conditions documentation.
- Distribution: Ensure the GDP compliance of the distribution centres.
- Product Quality Complaints: Ensure that quality complaints are registered and liaised with manufacturing site to trigger corresponding investigation and adequate corrective actions. Where necessary, liaise with pharmacovigilance department.
- Change control, deviations and CAPA As- Administer, maintain, and develop systems for change control, and deviation and CAP A handling.
- Suppliers/manufacturers & 3rd party service providers: Maintain, monitor & approve a list of approved suppliers, and Ensure that Quality Agreements are drawn up and kept updated.
- Archiving: Ensure that relevant quality related documentation is archived as required.
- Authority inspections and audits: Assist with GMP/GDP related competent authority inspections and perform or co-ordinate internal audits of the compliance of the Quality System.
- Bachelor in chemistry, pharmacology, or relevant tertiary qualification
- At least 5-10 years in both Quality Control and Quality Assurance
- Manufacturing experience is essential
- Proven experience as a quality assurance specialist or relevant role within the Pharmaceutical, Medical Device or Animal Health industries
- Good knowledge of MS Office and databases
- Dealing with Contract Manufacturing organisations (CMO) would be an advantage
- Thorough knowledge of methodologies of quality assurance and standards
- Excellent numerical skills and understanding of data analysis/statistical methods
- Outstanding communication skills
- Excellent organizational and leadership abilities
- Ability to multi-task, prioritise and work under pressure within strict deadlines
- Generous leave, health, and wellbeing benefits
- Commitment to ongoing personal & professional growth via a blend of learning opportunities
- Parking available at our Macquarie Park site
- Opportunity to join a leading global organisation with a network of 37,000 employees operating in 60 markets, with 25 R&D sites
Please submit your CV and a cover letter responding to the selection criteria outlining relative keys skills and experience in relation to this role.
Please note that only shortlisted candidates will be contacted.
Reports To
Snr Quality Assurance Manager, Commercial Quality AU
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Teva's Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
