Scientia Clinical Research Ltd
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Scientia Clinical Research (SCR) is the first publicly funded purpose built early phase clinical trials center in NSW. In addition to first time in human and first time in patient studies the facility also supports other Phase 1/2 trials across a broad range of therapeutic areas. You will work with a cross-functional team of medical, clinical, scientific, nursing, pharmacy, laboratory and data management professionals highly experienced in the early phase development of new medicines.
Qualifications & experience
A science degree in life science or similar areas.
At least 3 years’ experience within a Quality Assurance role in a pharmaceutical, biotechnology and/or CRO environment. Investigational Site experience is preferred.
High level knowledge of GCP and relevant aspects of other GxPs.
Experience with Root Cause Analysis and CAPA management.
Experience in electronic QMS platforms
Knowledge of computerized system validation.
Excellent technical and clinical writing skills; excellent computer literacy esp. in standard MS package, eQMS and other databases.
Excellent organizational and interpersonal skills; including the ability to competently liaise and provide feedback to internal and external collaborators and stakeholders.
Tasks & responsibilities
Assist in assuring that clinical studies meet internal and regulatory requirements
Assist in the management of SCRs Quality Documents (e.g. SOPs, etc.) within ©Dot Compliance
Coordinate sponsor/CRO audits and inspections and support analysis of findings and ensure effective CAPA management within the required timelines. Record and track progress of audits/inspections within ©Dot Compliance.
Assist in the management of vendors and suppliers
Plan and conduct internal and external audits, ensuring timely resolution of audit findings.
Perform Investigation, Root Cause analysis and CAPA completion of Quality Events and Deviations.
Independently review Investigator Site Files.
Assist in the review of eQMS generated reports to monitor training, deviation, quality events, change control and other Dot Compliance activities as well as compliance of SCR staff with relevant requirements
Serve as GCP and other relevant GxP subject matter expert in the support of clinical study activities.
Assist in coordinating with the SCR CSVL new validation activities and monitor that change control and validation review requirements of existing systems are met.
Assist in assuring of compliance with equipment maintenance and calibration requirements
Assist in developing and delivering training programs to ensure staff is knowledgeable about quality standards and regulations.
Contribute to relevant Quality Document (e.g. SOPs, etc.) review and revision as required
Actively pursue ongoing personal development and training to ensure knowledge and skills are consistent with SCR and global compliance requirements; maintain personal training record accordingly
Other responsibilities as discussed with the SCR Manager
A non-profit organisation offering salary packaging benefit entitlements.
State-of-the-art facility close to the beach, shops and public transport including the light rail just in front of the building
Work closely with national and international pharmaceutical and biotechnology stakeholders
If you would like more information about this opportunity, please contact firstname.lastname@example.org and quote “Quality Associate” or apply using the form above.