About Us
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.
Location: Brisbane
Job type: Fixed Term 24 months
About The Job
The 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 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.
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
Soft Skills
* 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?
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.
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