Job Title: Quality Specialist
The role of a Quality Specialist involves providing leadership in batch release, operational quality, deviations and complaints management. This position is responsible for the review and approval of batch related documentation such as manufacturing formulas, instructions and specifications.
Key Responsibilities:
* Operational activities are performed in accordance with current Good Manufacturing Practice (cGMP) guidelines using standard operating procedures and within validated state.
* Production processes and areas must be audit-ready at all times.
* Quality Key Performance Indicators (KPIs) metrics are managed and communicated via department meetings and Quality Management Review.
* Exhibit quality behaviors by manufacturing, Engineering, Supply Chain and Quality departments and foster a culture of continuous improvement aligned with cGMP.
* Act as 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.
* Ensure work performed is in accordance with approved standard operating procedures and GMP documentation through direct involvement with Production and Engineering Management.
* Proactively identify opportunities for continuous improvement; potential risks; and cGMP deficiencies to processes and documentation. Work closely with Production and Engineering to implement appropriate improvement or corrective measures.
* Closely monitor and manage non-significant deviations ensuring they are closed within a timely manner. Support investigations and agreed actions are closed within expected lead-times.
* Manage Product Technical Complaints and associated investigations.
* Participate in internal and regulatory audits conducted by Quality and relevant regulatory agencies.
* Ensure established Quality KPI's are met, monitored, and communicated within Manufacturing, Engineering and Quality.
* In conjunction with Area Management ensure responsible areas are in a state of readiness for regulatory and customer audits with all information readily available.
* Perform reviews/audits of batch records as per approved QA checklist.
* Be responsible for the position of Authorized Delegate for the market release of manufactured products.
Qualifications:
* University degree in Engineering, Pharmacy or science-related discipline.
Requirements:
* Minimum 5 years experience in a cGMP regulated environment preferred, ideally with TGA or PIC/s requirements knowledge and experience.
Personal Qualities:
* Strong interpersonal skills with ability to build and maintain relationships with internal/external stakeholders.
* Strong organizational, planning and critical thinking skills. Has the ability to set and action priorities to meet objectives. Highly collaborative and 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 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.
* 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 Quality behaviours exhibited by manufacturing, Engineering, Supply Chain and Quality and a culture of continuous improvement is fostered and aligned with cGMP.
We offer challenging, purposeful work where you can develop consumer brands with passion and creativity. Grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
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