This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
The Quality Assurance Manager is accountable for the management of the cGMP Compliance and relevant Regulatory Licensing requirements for the PCI Melbourne Site. This position is responsible for hosting regulatory inspections and responding to inspection reports. This position will oversee, maintain and drive improvements in the Pharmaceutical Quality Management System, including GMP software, to ensure compliance to regulatory, and procedural requirements. This role will also be significantly involved in Quality Investigations and Root Cause Analysis, responsible for Supplier Management, Deviations, CAPA, Complaints, Audits (i.e. internal, external and regulatory), PQS monitoring/reporting and Quality Improvement Initiatives.
Job Responsibility:
Oversee the implementation and compliance of the Pharmaceutical Quality System at PCI Melbourne, including the ePQS
Oversee and approve PQS improvements
Oversee and conduct site/virtual/desktop supplier audits
Approve supplier and client Quality Technical Agreements
Oversee the internal audit programme and schedule adherence
Oversee inspection and audit preparedness
Host and participate in client and regulatory inspections
Support the completion of other compliance team responsibilities
Oversee training related to PQS functions
Maintain regulatory licences
Lead, support and oversee quality investigations
Lead, support and oversee corrective and preventative action completion
Manage and support the completion of Quality Monitoring Reviews
Manage and drive continuous improvements
Ensure all activities are performed in accordance with GMP, company SOPs and Health and Safety policies
Ensure timely and effective communication and escalation processes
Provide business continuity by performing responsibilities related to Quality Director, and other Quality Managers
Requirements:
Bachelor of Science, Pharmacy or related Discipline
Minimum +10 years experience in a cGMP pharmaceutical manufacturing facility, ideally in a Quality Assurance, Quality Control or manufacturing position
Excellent written and verbal skills with good attention to detail
Nice to have:
Two years experience in a managerial or supervisory role
Pharmacy or relevant science degree with manufacturing experience
Experience in customer and regulatory authority audits