Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.
We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.
That's why we want to make self-care as simple as it should be by being consumer-led always, with science at our core.
Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Telfast, Nature's Own, Cenovis & Ostelin we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.
This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers.
We are also proud to have been the first, large, pure consumer healthcare company to achieve B Corp certification with Australia in February ****. Today, with 2/3rd of our business certified, we continue to make progress towards global certification.
Join us on our mission. Health. In your hands.
About the job
Senior Quality Associate reports directly to the Site Quality Head and the Project Portfolio Management (PPM) Lead, and is responsible for providing leadership to the team in Quality related aspects of site projects.
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 and cross-functional role with key stakeholder management whilst assuring Quality in the areas of manufacturing, engineering, supply chain and Country Quality related to the establishment of new products or projects.
This role has true ownership of projects across the organisation with opportunities for regular senior management exposure. Beyond delivery of results this person will be able to shape processes, operating model and culture as Opella builds for the future.
Main Responsibilities
Responsible for the review and approval of batch related documentation such as manufacturing formulas, instructions and specifications.
Draft new/updated Bulk Specification
Execution of change actions related to system set up and routing of New Product Development (NPD).
Conduct initial setup checks for new Packaging, Bulk and FG codes
Work on change control actions related to Manufacturing Formula (MF) and Manufacturing Instruction (MI) update review and approvals.
Complete MI Pilot publishing in Veeva and when ready including final version
Approve SAP status changes as per approved change control
Implement a continuous improvement culture with respect to product and process
Publish bulk specification
Perform QDOC set-up and activation
Perform SYMTEM reviews
Perform Sample Manager set-up for new testing related to NPD.
Contribute to process and qualification deviations related to NPD.
Ensure operations are performed in accordance with cGMP using Virginia's standard operating procedures and within the validated state.
Review and approval of operational GMP documentation as needed.
About you
Education
University degree in Engineering, Pharmacy or a science related discipline
Experience
Ideally 8-10 years' experience in a cGMP regulated environment, with TGA or PIC/s requirements knowledge and experience
Industry background in either Consumer Healthcare, Pharmaceutical or Food industry
Strong ability to build and maintain relationships with internal/external stakeholders
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
Ability to work independently and as part of a team
Demonstrated Leadership capabilities
A flexible and adaptable approach
A strong dedication to the job combined with a willingness for self-development
Demonstrated good work ethic and attitude.
Technical skills
Technically minded, with an ability to investigate manufacturing issues and root cause analysis
Also have a good knowledge and understanding of GMP, GLP and GDP guidelines and regulations
Strong orientation for quality systems and methodologies to improve production outcomes. Understanding of manufacturing, quality control and quality assurance systems including
Ability to achieve project objectives within tight timeframes and to perform in a high-pressure environment
Why us?
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.
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