The Senior Quality Assurance Associate is responsible for contributing to the development, implementation and maintenance of the quality assurance program and related policies and procedures to ensure compliance with Good Clinical Practices (GCP) and other regulations.
Reports to Director Quality Assurance
- Manage the planning, conduct, reporting and closure of study audits to ensure that the study was conducted in compliance with applicable regulatory and organisational procedures:
- Auditing of Trial Master Files
- Auditing of Study Databases
- Auditing of Clinical Study Reports
- Internal audits in accordance with approved Audit Schedule, facilitate internal facility, process and vendor audits.
- Act as Audit Coordinator and host/ co-host 3rd party audits and inspections.
- 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.
- Maintain an up-to-date knowledge of the latest requirements relating to GCP and regulatory requirements in Australia and overseas.
- Other duties as directed by Line Management or delegate.
- Ordinary degree in the appropriate discipline (e.g. Bachelor of Science) or equivalent experience.
- Minimum 4-5 years’ experience as a Senior Quality Assurance professional in the pharmaceutical industry operating in a GCP or GxP environment.
- Formal audit training or evidence based internal audit training.
- Knowledge of 21 CFR Part 11 and its implementation.
- Demonstrated ability to prioritise work and handle deadline pressure.
Please get in touch if you are interested in the role.