Quality Projects Senior Associate

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** Quality Projects Senior Associate**
* **
* Location:

Brisbane***
* *** Job type:
Fixed Term 24 months
*** 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 2025. 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
** 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 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
** 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
*…