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.

About Serb Pharmaceuticals

Serb Pharmaceuticals provides rescue medicines typically used in emergency rooms and intensive care units to treat patients for whom there are limited treatment options. We are dedicated to delivering quality medicines that make a real difference to patients and their families through the development, manufacture, and commercialisation of pharmaceutical products. Our current portfolio of antidotes counteracts certain snake venoms and the toxicity associated with some heart and cancer medications.

Broad Function

To be aware of and follow Serb’s Quality Policy. To provide support in the management of Quality System and eDMS (Proquis 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

• Serb Pharmaceutcials 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 Department of Agriculture.
• Issue manufacturing records for immunising, bleeding and serum production in accordance with prepared schedules.
• Reconcile all manufacturing records when returned to QA.
• Review and audit manufacturing records and processes for compliance with SOPs and GMP requirements.
• Ensure deviations, CAPA and other discrepancies related to batches are reconciled and investigations closed out in timely fashion.
• Assist departments in the creation of training curriculums and documentation
• 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.
• Prepare, review, revise and verify controlled documents as required through eDMS system
• Update related training documents and manage training records for all departments.
• Distribute, reconcile and manage archiving/destruction of Quality Management System documentation.
• Assist with Validation impact assessments, FMEAs and projects as required from a QA perspective
• QA review of Validation documents from other departments

Education and Experience

• An educational background in Biological Analytical Science is preferred (i.e. Microbiology, Biotechnology, Chemistry, Biochemistry, and Immunology)
• Previous experience in a Quality Assurance role is preferred but not essential
• Previous experience in a regulated industry, ideally a GMP environment is preferred but not essential 

Skills and Attributes

• Literacy, numeracy and good keyboard skills are imperative
• Proficient IT skills particularly in Excel and Word
• Confident with the ability to work with employees at all levels of seniority utilising excellent communication skills, both on an internal and external basis.
• Competent, methodical, highly organised individual who pays strict attention to detail and has the ability to effectively prioritise and execute tasks accurately within a high-pressure environment. Organisational skills should be strong with ability to plan ahead and multi-task with minimal supervision.
• Must be able to work as part of a team and demonstrate initiative when required with a flexible and willing attitude at all times

Company Benefits

• Employee Assistance Program
• Quarterly Performance Related Bonus
• 5 Weeks Annual Leave
• 3 days of additional Christmas Leave

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.