Quality Advisor

POSITION DESCRIPTION

Quality Advisor

Location:      NZCR

Reports to:   Quality Manager

Purpose of the Role/Position Summary

Ensure that QMS within the company is maintained at the highest possible levels. Ensure that NZCR operates to ICH-GCP, ISO 14155 standards and in compliance with other relevant quality regulations. Ensure the ongoing commitment to quality and risk management is developed and maintained ensuring effective structures and processes are in place to meet and maintain clinical trial regulatory standards by NZCR personnel.

KEY TASKS/RESPONSIBILITIES/OUTPUTS

• Develop a continuous improvement process for the business.


• Assist the maintenance of Q-Pulse quality management system.


• Conduct document control / document management processes; writing and reviewing policies, procedures and to deliver quality related training programmes.


• Conduct internal audits to ensure studies and NZCR activities are conducted in accordance with SOPs, sponsor protocols, ICH-GCP and other applicable guidelines and standards.


• Conduct audits of vendors, ensuring their compliance with contractual obligations, trial protocol requirements and regulatory standards.


• Support audits conducted by external sponsors, clients, and regulatory authorities.


• Manage the CAPA system, ensuring CAPAs are effectively implemented within agreed timeframes.


• Conduct root cause analysis investigations.


• Conduct UAT validations of computer software systems.


• Assist in the management of privacy and confidentiality regulatory requirements.


• Assist with leading quality meetings and attending other applicable meetings.


• Other quality assurance and quality control activities as required.


• Any other duties as directed by the CEO, COO or Head of Quality.

MINIMUM POSITION QUALIFICATIONS

Education:     Ideally possess some formal quality training e.g. auditing

Good understanding of and a current certificate in ICH-GCP (training will be provided)

                   Preferred training in ISO9001 (2015)

Experience:    Preferred 2-3 years’ experience in a quality role.

        Previous experience in a Research/Health/Medical industry.

        Previous experience working with Q-Pulse preferred, but not essential.

        Experience in conducting root cause analysis investigations.

        Experience in conducting UAT validations of computer software systems.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED

• Knowledge of research methodology and data management.


• A strong work ethic. Reliability, enthusiasm, and a positive attitude.


• Respect the confidentiality inherent in the role.


• Exceptional attention to detail.


• Excellent communication and people skills. Ability to communicate effectively, both verbal and written.


• Good knowledge of the national and international Regulatory and ethics principles, and procedures governing clinical research including ICH-GCP.


• Ability to gather information/data, compile information, prepare reports, and meet timelines.


• Strong organisation skills and the ability to prioritise work and work independently.


• A logical and organised approach to problem solving, and ability to put information in context/perspective.


• Skilled in the use of Microsoft Office applications e.g. Word, Excel, and Outlook.

This Position Description reflects the present position and is subject to review and alteration in detail and emphasis in light of future changes or developments. This would be done in consultation with the incumbent.

I have read and understood the above position description and accept all the above responsibilities incorporated.

Signed:                                                                          Date:

Employee’s name: