Zoetis has manufacturing network of 29 sites worldwide, and following our acquisition of Jurox Australia, located at Rutherford in the Hunter Valley, we are now seeking to employee current team members in our Quality Department.
**Position summary**
The QC Chemistry Compliance person will monitor and assist with the coordination and execution of compliance related activities. This role includes but is not limited to review of QC records and procedures, support of QC in the planning and execution of investigations (OOS/OOT/LI/NCR), periodic validation review, method validation / re-validation, and support of QC projects including equipment qualification and computerised system validation.
**Position responsibilities**
Primary Roles
- Prepare metrics for laboratory QMS compliance reporting.
- Work with QC Operations Team Leader in the coordination of resource for QMS action completion.
- Review of QC documentation and records for technical correctness and GMP compliance.
- Complete periodic method validation reviews.
- Prepare protocols for method validation / re-validation of existing commercial methods.
- Provide assistance to analysts during OOS/MDD and NCR investigations to effectively determine root cause and implementation of corrective action.
- Contributing to the efficiency of the laboratory by ensuring instruments, equipment, labware and work areas are maintained in a GMP compliant state.
- Develop and maintain quality control documentation such as specifications, test methods and standard operating procedures.
- Work with QC Manager to formulate a plan to address any deficiencies with the aim of continuous improvement and streamlining current processes.
- Participate in projects such as CAPEX projects, implementation of laboratory computer systems, and equipment qualification.
- Contribute to the development, implementation, communication and maintenance of quality control systems to comply with APVMA, EU and FDA cGMP requirements
- Comply with national and international standards and legislation
- Promoting quality achievement and quality performance improvement across the organisation.
Secondary Roles
- Support testing of products for validation and stability where necessary.
- Maintaining up-to-date laboratory records for all testing, analytical work and investigations carried out
- Investigate and report findings on complaints or other problem investigations, as requested by the QC Manager or their delegate
- Filing and storage of quality documents and records.
- Carry out other laboratory duties as directed by the QC Manager or their delegate.
**Education and experience**
- Bachelor Degree in; Chemistry, Life Sciences, Pharmaceutical, Quality Management or Science.
- Operational excellent training / certification highly desirable.
- Formal training in root cause analysis and risk assessment highly desirable