QA Specialist

3 days ago

Melbourne, Australia Avance Clinical Full time

The QA Specialist (CSV) is responsible for supporting the development, implementation, and maintenance of the Computerised systems at Avance and participating in Avance quality assurance program as per related policies and procedures to ensure compliance with Good Clinical Practices (GCP) and other
regulations.

Core Responsibilities
- Liaise with CSV / System Owners to maintain the computerised systems in a validated state at all times.
- Review and approval of proposed and executed changes for CSV related projects (e.g., new system implementations, major upgrades).
- Engage in the responsible monitoring of computerised system purchases, installation, validation, continued evaluation to decommissioning of systems using a risked based approach.
- Review of vendor supplied CSV documentation (e.g., change request, risk assessment, validation plan, software/configuration/functional specifications, IQ/OQ/PQ, traceability matrix, validation report).
- Review and approval of internal CSV documentation (e.g., initial assessment, change control, URS, risk assessment, validation plan, software/configuration/functional specifications, IQ/OQ/PQ, traceability matrix, validation report).
- Ensure annual reviews of user access and periodic reviews are performed for computerised systems and actively participate in this process through review / approval of the documentation.
- Communicate with the CSV team, System Owners and the Manager, Quality Systems and CSV
- Active member of the Avance CSV Committee / back-up minute taker during routine CSV Committee meetings.
- Ensure regulatory requirements are applied and adhered to as applicable throughout the CSV life cycle of regulated systems.
- Conduct internal process audits to verify compliance with internal processes and applicable regulatory requirements.
- Perform vendor audits and assist with audits conducted by sponsors.
- As required, contribute as a member of the investigational team for CAPAs.
- Coordinate preparation, review, and issue of Standard Operating Procedures (SOPs) to support and maintain quality systems and/or validation procedures.
- Maintain an up-to-date knowledge of the latest requirements relating to CSV, GCP and regulatory requirements in Australia and overseas.

Qualifications, Skills and Experience
- Bachelor’s degree (preferably in a science field) or equivalent experience.
- Minimum 2 years’ experience in a CSV capacity in a GxP (preferably GCP) environment
- Minimum 2 years’ experience as a Quality Assurance professional operating in a GCP or GxP environment (preferably GCP) environment.
- Formal audit training or evidence based internal / study audit training.
- Knowledge of GAMP 5 is essential.

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