Senior QA Officer

Current Opportunity

SERB Specialty Pharmaceuticals is a global specialty pharmaceutical group focused on prescription medicines which address rare and life-threatening diseases.

Following strategic acquisitions and targeted developments, SERB has succeeded in establishing a consistent drugs portfolio focused on niche specialty pharmaceuticals to ensure continuous availability of life-saving medicines and answer unmet medical needs.

Our commitment is to continue to offer essential drugs meeting Public health needs.

The function of the Senior Quality Assurance Officer is to provide support in the management of Quality System and eDMS (TrackWise Digital and ComplianceWire). Assist the Quality Manager and the Quality Department across both Turretfield and Martindale sites in all areas of the Quality System.  To support personnel at all levels in the understanding and implementation of Quality System, documentation and its effectiveness.

Principle Responsibilities

BTG Australasia manufactures to Good Manufacturing Practice (cGMP) standards within a rigorously regulated industry.  There is a fundamental requirement for duties be undertaken in compliance with relevant Standard Operating Procedures (SOPs) and to a standard that meets regulatory requirements, including TGA, FDA and AQIS.

• Maintain Manufacturing Records including allocate manufacturing batch numbers for scheduled immunisations, bleeding and serum production.
• Ensure deviations, CAPA and other discrepancies related to batches are reconciled and investigations closed out in timely fashion.
• Provide support for the eDMS system – TrackWise Digital and ComplianceWire.
• Assist departments in the creation of training curriculums and documentation
• Provide training in GMP requirements as required.
• Represent QA for discussion of CAPA incidents, risk assessment and agreement on corrective and preventive actions.
• To perform and participate in internal and external audits as required according to the audit schedule including TGA and DA (and any other external companies that may audit BTG) in both the front and back offices.
• Assist with Validation impact assessments, FMEAs and projects as required from a QA perspective
• QA review of Validation documents from other departments.
• Review of Sheep Health Status Notifications
• Tracking and managing of external suppliers ensuring that all supplier assessments, periodic reviews, Quality Agreements and audits are current and completed.
• Annual Product Quality Review

Serb Specialty Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.