Quality Officer

Job Title: Quality Officer

Location: Barangaroo, Aus

Job Type: Permanent

Purpose of the role:

To provide leadership in the management of Market Batch Release, oversight of Product Technical Complaints and support the Quality team in maintaining the company’s Quality System. Management of these key areas is important role within business as this is commonly the area that detects issues that can be serious in nature. This role will also be responsible for product release to market and when required will assist in rework review.

Main responsibilities:

Quality Complaints and Product Release

• Work with the regional and global hub to ensure timely and appropriate handling of complaints

• Act as point of escalation for the hubs for any complaints that require higher level management

• Interface with third party manufacturers regarding complaint information

• Manage complaint sample process (where available) ensuring they are sent to manufacturing sites in appropriate

• Enter Investigation Results from third party manufacturers into complaints database once received.

• Notify the relevant business roles regarding complaints and manufacturing site responses.

• Create complaint reports to be distributed to designated management within Sanofi, as determined by

• management.

• Communicate evaluation/investigation results to complainant/reporter once the complaint is completed.

• Monitor complaints reports for any negative product trends.

• Provide support (as needed) to internal customers (Safety Surveillance, Customer Service, Medical Information) relating to product quality complaints.

• Develop a close working relationship with sources of supply for complaint resolution and product

• release to market.

• Provide training on quality systems as required.

• Perform product release to market in an efficient manner ensuring appropriate prioritization.

• Provide support to other functions of the Quality team as required.

• Participate in projects as required.

• Review and maintain any local quality document required for the role.

• Where required, review and approve GMP documentation including masters, specifications, change controls, deviations, reworks, and others.

• Provide support (as needed) to internal customers (Commercial, Supply, Reg Affairs, Medical etc) relating to manufacturing, packaging, and quality.

• Support simplification initiatives

Health, Safety and Environment

Cooperate with Management to:

• Provide and maintain systems of work and working environments that are safe and without risks to health.

• Provide the information, instruction, training, and supervision necessary to ensure the health and safety of employees.

• Consult with employees about OHS matters so that they can contribute to decisions affecting their health, safety, and welfare.

• Ensure the health and safety of people visiting or working who are not employees by not exposing them to risk.

• Comply with corporate and legal health and safety requirements.

• Identify and correct unsafe conditions or behaviors and immediately notify the Manager of any serious incidents; complete an Incident / Injury Report and forward to Human Resources within 48 hours where necessary.

• Undertake duties in accordance with the current Sanofi Policies and Procedures.

• Report non-conformance in accordance with the requirements of the Sanofi quality system.

About you:

• Experience: pharmaceutical industry

• Education: Tertiary qualification within life sciences, science, or related discipline

• Soft skills: Excellent written and verbal communication skills, proactive and keen to learn.

• Technical skills: Knowledge of relevant codes of GxP and manufacturing and warehousing operations. Good document management skills