Quality Compliance Specialist
Our client is a large scale multinational pharmaceutical company in Sydney. They are currently looking for Quality Compliance Specialists to join their team in Sydney.
The client is looking for a Quality professional who will champion compliance and be accountable for the Quality Management System element assigned to them.
• Assists in development and maintenance of the Site Quality Management System
• Administer the Deviation and Investigation Management system (Quality Notification System) and trend site KPIs for global, regional and local management forums.
• Develop and manage the internal audit schedule; ensure that audits are conducted in a timely manner by self or other trained internal auditors, issue internal audit reports and track closure of internal audit observations to completion. Develop and maintain a pool of trained auditors on site through training and coaching with L&D.
• Ensure site readiness for regulatory and corporate (WWAG) inspections, prepare responses to inspections, track observations to completion and maintain the closure evidence folders. Track and trend site KPIs for global, regional and local management forums.
• Drive the site Vendor Management System. Administer the supplier database for site entries (including review and update of local suppliers and supplier audits as required). Track and trend site KPIs for global, regional and local management forums.
• Maintain the Product Quality Review (PQR) System by developing the schedule, completing assigned PQRs, managing the approvals ensuring due dates are met and recommendations are tracked.
• Manage site Customer Complaints, enter and track all complaints on the Global Complaints System, escalate as per procedure. Assist in investigation of complaints where required and ensure responses are issued within due date.
• Administer the Site Change Management process, ensure the relevant stakeholders assess changes. Ensure changes are being implemented and documented appropriately and within due dates.
• Administer the Site Quality Agreements and GMP Agreements with Local Contractors.
Education, Qualifications, Skills and Experience
• Tertiary qualifications in a science or quality related discipline
• Minimum 2 years working experience in a Pharmaceutical environment in Quality Control and/or Quality Assurance, ideally with experience also in production
• Ability to understand requirements prescribed within cGMP guidelines and how to apply these principles to maintaining compliance standards
• Demonstrable team working skills
If you would like further Information you can contact the recruiter directly:
Claire Kenny | Tel: +353 (0) 1 507 9287