QA Systems & Compliance Lead

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** QA Systems & Compliance Lead**
* **
* Location:

Virginia, Brisbane***
* *** Job type:
Fixed
- Term Contract- 24 months
*** 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
** Natures Own, Cenovis, Ostelin, Telfast, Buscopan and Bisolvon.
**** 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
** About the job
** Providing leadership and strategic direction, the
** QA Systems & Compliance Lead
** will shape processes, operating model and culture as Opella builds for the future!

The
** Quality Assurance Systems and Compliance Lead
** reports directly to the Site Quality Head and Project Portfolio Management (PPM) Lead.  They are responsible for all Quality Assurance and Validation activities for all site Projects and also the introduction of existing and new product developments (EPD and NDP).  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 will represent all quality related activities for the site at the Quality Leadership level.
** Main Responsibilities*
* * Development of Validation protocols, execution and reports.
* Completion of all actions necessary for the NPD (as required), validation or assessments.  Update of validation matrix.
* The update of the stability program for NPD to assure ongoing stability testing incorporating the new product and if grouping is appropriate, including all related documentation such as the stability matrix.
* Review and approval of Change Controls and ensuring impact assessments are completed.
* Providing technical input in the Technical Transfer and scale-up process from DC to M&S
* Supporting development and providing guidance on the manufacturing instructions, master formulations and bills of materials
* Management of deviations (commercial batches or trials) required to assess proposed change prior to CC
* Support DC in formulation development
* Evaluation of raw materials for EPD/NPD
* Involvement in the VISTA label creation process
** About You
**** Education**:
* University degree in Engineering, Pharmacy or a science related discipline
*
* Experience:

*** Minimum 12 years’ experience in cGMP regulated environment, ideally with TGA or PIC/s requirements knowledge and experience ***(Fast moving Consumer Healthcare, Food or Pharmaceutical industry background preferred)
**** Min 3 years leading teams / supervisory experience, Proven ability to lead teams in validation, stability or quality assurance.
* Sound understanding cleaning validation, process validation, stability, equipment qualification and facility and utility qualification.
* Demonstrated and successful track record in successful technology transfer activities that resulted in commercial product.
* Ability to clearly and concisely express ideas in spoken and written communications
** 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…