Quality Associate

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Opella is the self-care challenger with the third-largest portfolio in the OTC & Vitamins, Minerals & Supplements market globally. Our mission is to bring health in people's hands by making self-care as simple as it should be for over half a billion consumers worldwide. We have 100+ loved brands, an 11,000-strong global team, 13 best-in-class manufacturing sites and four specialized science and innovation development centers. Headquartered in France, Opella is the maker of brands including Natures Own, Cenovis, Ostelin, Telfast, Buscopan and Bisolvon. We are B Corp certified in multiple markets.

About The Job: The Quality Associate reports directly to the Quality Compliance Lead and is responsible for providing leadership in batch release, operational quality, deviations and complaints management. This role reviews and approves batch-related documentation such as manufacturing formulas, instructions and specifications. Products manufactured at the Virginia site comprise listed and registered complementary medicines and a growth view for OTC products, with distribution locally in Australia and within the Asia Pacific region. It is a highly collaborative role with key stakeholder management across Manufacturing, Engineering, Supply Chain and Country Quality.

• Operations are performed in accordance with cGMP using Virginia's SOPs and within the validated state
• Production processes and areas are audit ready at all times
• Quality KPIs are managed and communicated via department meetings and Quality Management Review
• Foster a culture of quality behaviours and continuous improvement aligned with cGMP
• As QA representative, be the first point of contact for issues that may result in changes or deviations from a validated system or process that may impact product quality or safety
• Ensure work performed by Production and Engineering aligns with approved SOPs and GMP documentation
• Identify continuous improvement opportunities, potential risks, and cGMP deficiencies; work with Production and Engineering to implement improvements or corrective actions
• Close non-significant deviations in a timely manner; support investigations and actions to closure within lead-times
• Support the business to maintain TGA license
• Manage Product Technical Complaints and related investigations
• Participate in internal and regulatory audits conducted by Quality and regulatory agencies
• Ensure Quality KPIs are met and communicated across Manufacturing, Engineering and Quality
• Prepare areas for regulatory and customer audits with information readily available
• Review/audit batch records as per QA checklist
• Act as Authorised Delegate for market release of Virginia site manufactured product
• Review and approve batch-related documentation and operational GMP documentation as needed

Must be University degree qualified in Engineering, Pharmacy or a relevant science-related discipline.

• Ideally 6+ years' experience in a cGMP regulated environment in FMCG, Consumer Healthcare or Pharmaceutical Industry
• Experience with TGA (or equivalent), PIC/s requirements knowledge
• Exposure to Quality Assurance and Compliance, Batch release, investigations of deviations, CAPA closure, updating procedures

• Strong ability to build and maintain relationships with internal/external stakeholders
• Strong organisation, planning and critical thinking skills; ability to set and action priorities; highly collaborative with ability to influence and achieve results
• Ability to work independently and as part of a team
• Demonstrated leadership capabilities
• Flexible and adaptable
• Commitment to self-development and strong work ethic

• Technically minded with ability to investigate manufacturing issues and root cause analysis
• Knowledge of GMP, GLP and GDP guidelines and regulations
• Strong orientation to quality systems and methodologies to improve production outcomes; understanding of manufacturing, quality control and QA systems
• Ability to achieve objectives within tight timeframes and work in a high-pressure environment

At Opella, you will work on challenging, purposeful projects and be empowered to develop consumer brands with passion and creativity. This is a chance to grow new skills and be part of a bold, collaborative and inclusive culture.

We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. We Are Challengers By Nature.

Join us on our mission. Health. In your hands.

www.opella.com/en/careers