Description:
Quality Associate (FTC)-
Location : Virginia, Brisbane
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12 x month Fixed-Term Contract (2 x positions available)
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally .
Our mission: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide.
At the core of this mission is our 100+ loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and four specialized science and innovation development centers.
Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet.
Find out more about our mission to bring health in your hands at www.opella.com.
About the job:
The Quality Associate (FTC) reports directly to the Quality Compliance Lead and is responsible for providing leadership 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 n the areas of manufacturing, engineering, supply chain and Country Quality.
Main responsibilities:
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Operations are performed in accordance with cGMP using Virginia’s standard operating procedures and within the validated state
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Production processes and areas are audit ready at all times
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Quality Key Performance Indicators (KPIs) metrics are managed and communicated via department meetings and Quality Management Review
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Quality behaviors exhibited by manufacturing, Engineering, Supply Chain and Quality and a culture of continuous improvement is fostered and aligned with cGMP
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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
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Through direct involvement with Production and Engineering Management ensure that work performed is as per approved standard operating procedures and GMP documentation.
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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.
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Ensure non-significant deviations are closed within a timely manner. Support investigations and agreed actions are closed within expected lead-times.
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The management of Product Technical Complaints and associated investigations
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Participate in internal, and regulatory audits conducted by Quality and relevant regulatory agencies
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Ensure that established Quality KPI’s are met, monitored, and communicated within Manufacturing, Engineering and Quality
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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.
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Perform the review/audit of batch records as per approved QA checklist.
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Be responsible for the position of the Authorised Delegate for the market release of Virginia site manufactured product.
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Review and approval of batch related documentation such as manufacturing formulas, instructions and specifications.
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Review and approval of operational GMP documentation as needed
About you
Qualification :
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University degree in Engineering, Pharmacy or a science related discipline
Experience :
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Minimum 5 x years experience cGMP regulated environment preferred, ideally with TGA or PIC/s requirements knowledge and experience
Soft skills :
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Strong ability to build and maintain relationships with internal/external stakeholders
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Strong organisation, planning and critical thinking skills. Has the ability to set and action priorities to meet objectives. Highly collaborative and is able to influence and achieve results in a team environment
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Ability to work independently and as part of a team
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Demonstrated Leadership capabilities
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A flexible and adaptable approach
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A strong dedication to the job combined with a willingness for self-development
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Demonstrated good work ethic and attitude
· Technical skills :
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Technically minded, with an ability to investigate manufacturing issues and root cause analysis.
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Also have a good knowledge and understanding of GMP, GLP and GDP guidelines and regulations.
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Strong orientation for quality systems and methodologies to improve production outcomes.
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Understanding of manufacturing, quality control and quality assurance systems including Quality behaviours exhibited by manufacturing, Engineering, Supply Chain and Quality and a culture of continuous improvement is fostered and aligned with cGMP
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
www.opella.com/en/careers
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