Quality Associate; FTC

Position: Quality Associate (FTC)
#
** Quality Associate (FTC)*** ##
*
* Location:

Virginia, Brisbane*** ##
** 9 x month FTC
** opportunity

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
** The
** Quality Associate
** 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 and accountabilities include:
*
* Main Responsibilities:

*** Operations are performed in accordance with cGMP using Virginia’s standard operating procedures and within the validated state.
* Production processes and areas are audit ready at all times
* Quality Key Performance Indicators (KPIs) metrics are managed and communicated via department meetings and Quality Management Review
* Quality behaviours exhibited by manufacturing, Engineering, Supply Chain and Quality and a culture of continuous improvement is fostered and aligned with cGMP
* 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
* Through direct involvement with Production and Engineering Management ensure that work performed is as per approved standard operating procedures and GMP documentation
* 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
* Ensure non-significant deviations are closed within a timely manner. Support investigations and agreed actions are closed within expected lead-times
* The management of Product Technical Complaints and associated investigations
* Participate in internal, and regulatory audits conducted by Quality and relevant regulatory agencies
* Ensure that established Quality KPI’s are met, monitored, and communicated within Manufacturing, Engineering and Quality
* 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
* Perform the review/audit of batch records as per approved QA checklist
* Be responsible for the position of the Authorised Delegate for the market release of Virginia site manufactured product
* Review and approval of batch related documentation such as manufacturing formulas, instructions and specifications
* Review and approval of operational GMP documentation as needed
* All local Health & Safety requirements
** About you
**** Education**:
* University degree in Engineering, Pharmacy or a Science related discipline
** Experience**:
• Ideally 5 years’ experience cGMP regulated environment,…