About the company
Work within a large global Biotechnology company that boasts a good company culture that is always expanding.
 
About the opportunity
The Senior Quality Associate is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyses data and documentation.
 
Duties

• Ensure manufacturing areas are compliant according to regulations
• Working in EQMS systems, getting manufacturing release testing teams up to speed with compliance aspects
• Within the project – getting operationally ready, may need to write documents, review and approval of documents
• Qualification of instruments
• User requirements specifications
• Good knowledge of GMP
• Day-to-day operations plus project work

 
Skills and Experience

• Degree in a relevant biological science
• 5 Years’ experience in at least one of: manufacturing under GMP, Regulatory Affairs, Quality Assurance or relevant process development (experience regarded more highly than degree)
• In-depth understanding of GMP requirements in the pharmaceutical industry and previous production, Quality or R&D experience within the pharmaceutical industry including qualification and validation principles and applications
• Good interpersonal, negotiation and influencing skills
• Good analytical and problem-solving skills
• Ability to work well independently and to self-motivate
• Well-developed organisational and time management skills
• Experience with electronic batch review/release systems, SAP and StarLIMS

 
Culture
Although a large, global company, they are able to provide a family-like culture and prides itself in improving the lives of others.
 
Why this opportunity is right for you
This is a Full-time 12-month contract opportunity to work within an excellent team environment. Hybrid role working from home 2-3 days per week.
 
How to Apply
Click apply or contact Jo Turner, Senior Specialist Manager on 03 9938 7100 for a confidential discussion.