Senior Quality Associate- Clinical Trials Melbourne

Summary about this job

Detail information about job Senior Quality Associate- Clinical Trials Melbourne. Terms and conditions vacancy

Our Client is a one of the largest independent medical research institutes in Australia. Its scientific output, measured by citations and impact, places it amongst the top health research institutes in the world.

Reporting to the CEO we are currently recruiting for a Quality Associate: 

The Quality Associate is a key member of the CRO team and endeavours to ensure the team provides the best practice services the clinical trials sector. The Quality Associate, under supervision of Management, has responsibility for the company’s Quality Management System (QMS) to ensure that clinical trials outsourced are conducted in compliance with applicable GxP Guidelines, local and international Standards, applicable Regulations and best practices.

The role includes development and maintenance of ICH GCP compliant procedures, conduct of training and activities to support a Quality-based culture, hosting of client and regulatory audits and administering the Quality Oversight Team and any quality-related projects under the direction of the Quality Lead. The role is critical to ensuring company’s is audit ready at all times.

Key responsibilities:

• Develop and maintain ICH GCP compliant SOPs and associated documents to ensure a consistent approach to management of Clinical Trials

• Lead internal and external audit activities to ensure trials are conducted in accordance with sponsor protocols, ICH GCP, Industry Guidelines and applicable Standards, applicable Regulations and complete other audit activities (vendor audits, systems audits)

• Assisting the operational team in ensuring staff adhere to approved Standard Operating Procedures;

• Management and tracking of CAPA activities

• Management and Tracking of Risk Register

• Administer the Quality Oversight Team (QuOT)

• Support and encourage Continuous Improvement initiatives across Training and Best practice sharing

• Deliver on quality timelines as required with minimum oversight;

• Review of documentation to ensure Good Documentation Practices and compliance with SOPs;

• In liaison senior management, ensure personnel are compliant with SOPS and associated systems;

• Develop, implement and monitor quality improvement activities  within Institutional scope, in accordance with the relevant Policies as varied from time to time to meet global regulatory requirements;

• Adhere to Standard Operating Procedures and regulatory guidelines;

Qualifications, Skills and Attributes

• Degree in a Science, Life sciences or health-related discipline;

• Knowledge of ISO 14155 and ICH-GCP;

• Excellent oral and written communications skills including the ability to prepare audit reports, author policies and standard operating procedures;

• Excellent organisational skills with the ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate a number of tasks concurrently;

• Minimum of four (4) years’ experience in quality assurance in clinical research;

• An in depth understanding of clinical research requirements, local and global regulatory as applicable to Australia and New Zealand;

• Experience in Good Document Practice (GDP), Document management and

control;

• Experience in developing training materials and delivering training programs;

• Excellent interpersonal and team skills including the ability to network effectively, to work individually and as part of a team;

• High level computing skills (Microsoft Office at a minimum); Experience in Microsoft Sharepoint;

• Able to travel regionally, interstate and overseas as required by the business

• Prior audit experience or qualifications (Conducting Investigator audits, system

audits, internal audits

• Current driver’s license

To express your general interest please forward your CV and detailed covering letter to [email protected] or for a confidential discussion contact Maree Paras on 03 9029 3555 or 0423 789 789 or Georgia White 0497 855 072 for a confidential discussion. Please supply your CV in Microsoft Word format only.

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