Senior Quality Compliance Specialist

• Full time permanent position based in Melbourne or Sydney
• Newly created role to provide technical and quality support for a strong and expanding product portfolio!
• Join an expanding company that offers great learning and progression potential

Our client, one of the biggest pharmaceutical companies in Australia, is looking for a Senior Quality Compliance Specialist to join their Quality team to investigate and resolve complex quality and potentially significant compliance issues.
  
Reporting to the Technical Manager - Quality Assurance, you will be responsible for analysing complex scientific data, performing risk assessments and making recommendations / supporting the Technical Manager to lead cross-functional meetings to drive resolution and mitigation strategies.
  
Your other responsibilities will also include, but not be limited to:

• Evaluating product portfolio for potential impurities (ie. nitrosamine etc.) and coordinating assessment, investigation and testing with manufacturing sites
• Liaising with the regulator regarding risk assessment for compliance signals, non-conformances and recalls when needed
• Supporting business decisions related to quality and compliance risks
• Supporting risk assessment for product quality complaints and managing triage / escalation

This is a great opportunity for an experienced scientific compliance professional who has great analytical and stakeholder interaction skills to join a diverse and fast paced working environment, with a supportive and friendly team to excel your learning potential and fast track your career in the pharmaceutical industry!

  
To be considered for this role, you will have the following skills and experience:

• Tertiary degree in Chemistry, Pharmacy or other related Life Sciences fields (postgraduate qualifications would be highly regarded)
• Minimum of 5 years’ experience in technical quality or other compliance roles in the pharmaceutical industry
• Strong understanding of GMP principles
• Extensive knowledge of pharmaceutical manufacturing, packaging and testing processes and technologies
• Strong ability to perform risk assessment / management for complex quality issues, including nitrosamine management strategies.
• High level skills to absorb and disseminate complex information
• Excellent communication skills (both written and verbal)
• Ability to build effective and strong relationships with external and internal stakeholders
• Great understanding and exposure to TGA functions and nitrosamine impurity risk management will be advantageous!

If this sounds like you or someone you know and would like to know more about this exciting opportunity, please call Jason Mai on 02 9431 2*** for a more detailed and confidential conversation.