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About the company

This well regarded and successful pharma company seek to research, develop and manufacture innovative medicine to prevail against serious disease

About the opportunity

As Senior Quality Advisor, you will be responsible for ensuring relevant deviations and out of specifications, are investigated, and appropriate corrective and preventative actions are implemented; facilitating change controls and ensuring risks are effectively assessed and mitigated. Additionally, you will be the key compliance representative to manage and execute the qualification and validation program for the new manufacturing facility located in Melbourne.

Duties

• Management of R&D deviations and change controls
• Management of review and approval of key GMP documentation SOP's, plans, report, qualification, Quality Risk Assessments etc
• Facilitate and risk assess relevant change control for implementation
• Liaise with R&D departments regarding quality related issues associated deviations, change controls and out of specifications
• Lead the compliance execution of the qualification and validation program for the new manufacturing facility
• Provide compliance specialist advice on qualification and validation issues for the new manufacturing facility
• Actively participate in problem solving and identifying opportunities for improvement

Skills and Experience

• A degree in a relevant biological science, with at least five years' experience in at least one of: manufacturing under GMP, Regulatory Affairs, Quality Assurance or relevant process development
• 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

How to Apply

Click apply or contact Jo Turner (Senior Specialist Manager) on 03 9938 7120 for a confidential discussion.