- SalaryNegotiable
- LocationSydney
- Job type Full Time
- DisciplineQuality Assurance, Regulatory Affairs
- Reference38494
Quality Manager
Job description
About the company
A distinguished global pharmaceutical company with facilities worldwide. The company prides itself on compounding products of the highest quality by having a proactive approach to enhancing quality control. The company believes their best asset is their people and they are passionate about working collaboratively to make a difference to the lives of millions of people.
About the opportunity
As the Quality Manager, you will be supervising a team and overseeing the operations of all Quality related matters. You will be utilising your expertise to maintain an 'audit-ready' environment and implement strategies with a focus on continuous improvement.
Duties
- Review and implement strategies to enhance process performance and product quality
- Ensure the escalation and response to quality issues
- Authorise the release for supply
- Ensure the compliance with cGMPs and relevant regulatory guidelines
- Review and approve all Quality related documentation
- Maintain and enhance Quality Management systems to release or reject products, packaging, and labelling materials
- Oversee the management of CAPAs, deviations, complaints, and validation activities
- Be the primary point of contact for regulatory inspections and the response to observations and corrective actions required
Skills and Experience
- Bachelor's degree in a scientific related discipline
- Management experience in Quality Assurance and/or Regulatory Affairs within a TGA regulated and cGMP environment
- Ability to prioritise and problem solve
- Excellent communication skills
- Ability to maintain positive working environment and coach a team
- Proficiency in Microsoft applications
How to Apply
Click apply or contact Madeleine Byrnes, Sourcing Consultant on 0288778703 for a confidential discussion.
