DBG Health is an independent health, wellness, and beauty company with headquarters in Melbourne and over 700 professionals across the globe collaborating successfully to deliver affordable health, wellness, and beauty solutions for all.
About Arrotex Pharmaceuticals:
Arrotex Pharmaceuticals has a robust portfolio of ethical medicines offering the widest range of molecules made available through community pharmacies, supporting the health of patients. On average, patients access more than 104 million PBS prescriptions and 4.6 billion tablets of Arrotex prescription medicines in a year.
About the role:
Arrotex Pharmaceuticals is looking for a Senior Quality Compliance Specialist with the ability to assimilate complex information relating to pharmaceutical product quality and manufacturing site GMP compliance. The role will focus on identifying and evaluating compliance signals, performing risk assessments and recommending risk management action plans.
What your day might look like:
- Work with suppliers, Arrotex internal teams and TGA to resolve quality and compliance issues
- Oversee the implementation of corrective and preventive actions (CAPAs) including containment and disposition actions
- Prepare clear, accurate risk assessments supported by sound scientific rationale, with recommendations for corrective and preventive actions
- Support the Technical Manager to implement and optimise internal processes for compliance risk and issue management, triage and escalation.
- Provide support for a portfolio of manufacturing sites through the product lifecycle as required
- Collaborate with internal teams to identify opportunities for growth and improvement
- 5-10 years experience in a technical, quality, regulatory or related compliance role in the pharmaceutical industry
- Experience performing risk assessment for Nitrosamine impurities would be highly regarded
- Postgraduate LifeScience qualification with demonstrated ability to build and defend a robust thesis will be highly regarded
- Extensive knowledge of pharmaceutical manufacturing, packaging and/or testing processes and technologies
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Well developed organisation and time management skills with the ability to prioritise
- Online pharmacy
- Exclusive discounts
- Paid parental leave
- Novated car leasing
- Premium membership to Go1 online learning and development platform
At Arrotex we are committed to creating an inclusive workplace. We believe in equal employment opportunities regardless of age, gender, identity, ethnicity, physical and mental ability. Arrotex acknowledges and pays respect to the Traditional Owners and ongoing custodians of the land.