Role: Quality Associate

Location: Virginia, Brisbane

Grade: L1-1

Contract: 12-month FTC

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As an [Experienced Hire Role] , you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.

The Quality Associate reports directly to the Quality Compliance Lead and is responsible for accountability in batch release, operational quality, deviations and complaints management. This role is also responsible for the review and approval of batch related documentation such as manufacturing formulas, instructions and specifications. Products manufactured in the Virginia site comprise both of listed and registered complementary medicines and a growth view for the manufacture of Over The Counter (OTC) products, with distribution both locally in Australia and within the Asia Pacific region. This is a highly collaborative role with key stakeholder management cross-functionality whilst assuring Quality in the areas of manufacturing, engineering, supply chain and Country Quality.

Main responsibilities and accountabilities include:

• Operations are performed in accordance with cGMP using Virginia’s standard operating procedures and within the validated state.

• Production processes and areas are audit ready at all times

• Quality Key Performance Indicators (KPIs) metrics are managed and communicated via department meetings and Quality Management Review

• Quality behaviors exhibited by manufacturing, Engineering, Supply Chain and Quality and a culture of continuous improvement is fostered and aligned with cGMP

As Quality Assurance’s representative , be the first point of contact for any issue that may result in change to or deviation from a validated system or process that may impact product quality or safety.

• Through direct involvement with Production and Engineering Management ensure that work performed is as per approved standard operating procedures and GMP documentation.
• Proactively identify continuous improvement opportunities; potential risks; and cGMP deficiencies to processes and documentation. Work closely with Production and Engineering to implement appropriate improvement or corrective measures.
• Ensure non-significant deviations are closed within a timely manner. Support investigations and agreed actions are closed within expected lead-times.
• The management of Product Technical Complaints and associated investigations
• Participate in internal, and regulatory audits conducted by Quality and relevant regulatory agencies
• Ensure that established Quality KPI’s are met, monitored, and communicated within Manufacturing, Engineering and Quality.
• In conjunction with Area Management ensure that responsible areas are in a state of readiness for regulatory and customer audits with all information readily available.
• Perform the review/audit of batch records as per approved QA checklist.
• Be responsible for the position of the Authorised Delegate for the market release of Virginia site manufactured product.
• Review and approval of batch related documentation such as manufacturing formulas, instructions and specifications.
• Review and approval of operational GMP documentation as needed.

Health, Safety and Environment

• Provide and maintain systems of work that are safe and without risks to both workers health and the local environment.
• Provide the information, instruction, training and supervision necessary to ensure the health and safety of employees, plus the local environment.
• Consult with employees about HSE matters so that they can contribute to decisions affecting their health, safety, and welfare, as well as initiatives to improve sustainability and reduce our environmental footprint.
• 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, safety and environment requirements.
• Identify and correct unsafe conditions or behaviours and immediately notify the Manager of any serious incidents; complete and Incident / Injury Report and forward to HSE within 48 hours where necessary. This includes any harm to the local environment.
• Undertake duties in accordance with the current Sanofi Policies and Procedures.

• Report non-conformance in accordance with the requirements of the Sanofi Quality and HSE systems.

This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella.