Quality Systems Coordinator

POSITION SUMMARY

Support Quality Systems in Melbourne and Wellington Manufacturing Sites

POSITION RESPONSIBILITIES

Provides support for the Quality Function with regards to the Site Quality System and Quality Policies/Standards.

Support ICHQ10 compliance for the site .

Through Key Quality Performance Indicator Dashboard, monitor site quality systems performance to ensure they consistently remain in place, in use and in control, comply with Zoetis Global Quality Policies and Standards and meet the most current regulatory requirements and best industry practices,.

Assure that the site Quality Systems and Quality Tools are designed, deployed and maintained across the site organization to support the product lifecycle and are aligned, lean and efficient. Quality systems and Tools are In-Place, In-Use and In-Control. Quality tools are maintained in a validated state.

Owns the Quality Manual for the site GMS operations. The Quality Manual houses all Quality Standards, Processes, and Quality related governance aspects for Quality (QA and QC) and Operations at the site.

Establish links to VMRA and other compliance surveillance vehicles to develop and keep the Site Key Points of Compliance up to date and appropriately deployed throughout the Quality Management System in compliance with local regulations and Zoetis Global KPCs (match-up with the Center QSS function).

Monitor Quality metrics to drive continuous improvement throughout the site GMS organization.

Ensure GMP documentation system is properly managed and archived.

Manage Raw material/API/ABI Supplier /Service Provider approval-qualification-certification program.

Manage the Change Control System.

Manage the LMS training system.

Support the development of quality goals and targets as part of the organization’s quality strategic plan.

Support Raw Material & Printed Material Release tasks.

Manage Customer Complaint System.

Participate in the QO Internal or External Regulatory audits and vendor audits including acting as Lead Auditor for Internal Audits and issuing audit reports when required.

Follow-up action item replies from internal and external audits using audit database and issue close out notices for completed audits.

Assessing documentation and minor change controls as required.

Assist with the assessment and progression of major change controls.

Perform and administer Quality Training as required.

Support the management of ZLIMs

ORGANIZATIONAL RELATIONSHIPS

Site Manufacturing and Support Teams

Site Leadership & Enabling Functions

Cross functional teams within GMS & GMT

External parties including suppliers & service providers

EDUCATION AND EXPERIENCE

Biochemical / Microbiological Degree or equivalent qualification.

Quality Control Background

TECHNICAL SKILLS REQUIREMENTS

Proven Organisation skills

High level of knowledge of the Australian cGMP and the Australian / NZ Veterinary cGMPs

Knowledge of the Zoetis Quality Standards and Systems

High level knowledge of Quarantine Approved Premises Criteria

Knowledge of vaccine manufacturing processes

Communication skills (interpersonal and written)

Computer skills (LIMS / Microsoft programs)

PHYSICAL POSITION/QUALIFICATION REQUIREMENTS

The site is a GMP facility with climate & environmentally controlled with clean and classified areas within.

This position is located both in an office environment and within the Production areas. The incumbent will be required to wear various manufacturing suits dependent on the production activities being performed.

The attires include:

· Lab coat, steel-capped safety boots, hairnet, beard snood (where applicable), and safety glasses (where signposted)

· Primary gowning (for controlled area work)

· Secondary gowning consisting of sterile gown, boots, mask, gloves and safety glasses/ googles (for aseptic operations)

No special clothing requirements for all office based activities (street clothes only)

This job requires the employee to work overtime as needed