Quality and Compliance Manager

Quality and Compliance Manager

Proclinical are working exclusively with an Eastern Melbourne based CMO, who are looking for an individual with the kind of soft skills, and strategic understanding to support a Quality Director.

Role Overview:

Reporting into the Director, you will be expected to liaise with internal and external stakeholders using intelligence and business acumen help drive the company forward. Such as interact with client and other external parties (TGA, DHHS) licencing requirements and to manage the cGMP Compliance for the site.

Job Duties:

• This role will maintain and report quality metrics and host Quality Management Review forums and other meetings to progress quality performance.
• Lead the onsite and virtual audits/inspections
• Oversee quality investigations, complaints
• Improve site performance through CAPAs and continuous improvement tools
• Ensure documentation and tracking of vendor questionnaires & self-assessment/desktop audits
• Implement, track and maintain GMP/Quality Technical Agreements for all clients

Applicant Requirements:

• Bachelor of Science, Pharmacy or related Discipline.
• 5 years’ experience in cGMP pharmaceutical manufacturing facility, ideally in a Quality Assurance, Quality Control or manufacturing position.
• Excellent written and verbal skills with good attention to detail
• Documented cGMP training.
• Victorian Government Police Check