Quality Control Systems Senior Specialist

4 months ago

Upper Hutt, New Zealand MSD Full time

Exciting **Permanent Full-Time **role with an innovative global Animal Health business
- Bring your innovative streak, curiosity, and **learning spirit **into a career of **purpose** and **personal growth**.
- Your chance to be at the center of innovation and excellence in execution.

Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are an international team of professionals working together to make a positive difference in animal care and the world's food supply, and we have a deep sense of responsibility toward our customers, consumers, animals, society, and our planet. We offer one of our industry's most innovative products, services, and technologies to prevent, treat, and control diseases across all major farm and companion animal species.

**Over View**:
The primary responsibility of the Quality Control (QC) Systems Senior Specialist is to provide technical leadership and support for Quality Control laboratory systems at the Whakatiki and Whiteman's Valley testing facilities to ensure testing is completed to technical, quality, and regulatory requirements.

As the QC system expert, you will support the implementation of robust equipment, processes, test methods, and procedures to complete Quality Control testing in line with global quality policies, quality standards, current Good Manufacturing Practices, and registration requirements.

The QC Systems Senior Specialist role sits within the Quality Group organization and reports to Site Quality Head.

**What will you do**:
**Quality Control Systems Technical Oversight and Continuous Improvement**
- Assist in the development of Data Integrity (DI) improvement through personal example, coaching/mentoring, and formal/informal training sessions
- Information Technology (IT) systems assessment and harmonization, improvement of technical and operational processes and systems.
- Proposing, sourcing, coordinating, and implementing new equipment, monitoring and maintaining the validated state of test methods and equipment to align with the Method Robustness program.
- Managing Change controls for the Quality Group, ensuring suitable calibration and maintenance programs are maintained for equipment in use.
- Leading software improvements and implementation, benchmark and remain current with developing new technologies in the vaccine and biopharmaceutical processing field of expertise, and seek to deploy process improvements through innovation and utilization of these technological advances.
- Establish and monitor method performance to identify improvement required
- Troubleshooting and problem-solving, and maintaining up-to-date knowledge of international, technical, instrumental, and analytical developments

**Quality Control Operation Support**:

- Participating in the development, and revision of company policies, guidelines, procedures, and implementation in the site
- Manage and aid others in improving GMP systems on a project basis across the site.
- Reliance: Coordination to determine needs and participation in establishing priorities: Change Control, Events, Corrective Action, and Preventative Action (CAPA)

**Data Integrity (DI) System Improvement & Auditing**:

- Function as DI lead for the site to coordinate data integrity improvements agreed upon with site leadership
- Monitor improvements and provide feedback in terms of status reports
- Active participation in the DI community
- DI communication to site leadership and relevant areas.
- Assist in the periodic review of company GXP-related systems and processes.
- Perform technical internal and external subcontracting laboratory audits and generate formal reports as required.

**Communication**
- Provide information to requests with the assurance that the data is valid and accurate.
- Provide support to the business as a whole where requested.
- Work as a facilitator to coordinate activities to enhance the performance of the group or project.
- Conduct in a professional manner that meets Company and HR policies.
- Fostering a culture supporting quality and technical excellence in the Laboratory. Ensures adherence to high-quality standards, investigates problems, develops solutions, and makes recommendations to management.
- Maintain all documentation in accordance with Company and relevant quality standards.

**Quality Management Subsystem Owner**:
Be responsible for the ownership of the AHQM Sub-Chapters as nominated and agreed upon by the Site Quality Head.
- Demonstrate detailed knowledge of the Quality Manual and Location, the site policy and procedures, and the relevant Core Requirements.
- Providing proactive direction concerning subsystems with a view to execution. Focus on continuous improvement through regular reviews and periodic feedback to the system owner. Support the SO to highlight gaps and propose solutions to the Site Quality Council and Quality Assurance.
- Proactive participation in the preparation

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