Quality Systems Specialist

8 hours ago

Upper Hutt, New Zealand MSD Full time

**Quality Systems Specialist**

**The Opportunity**
- ** Permanent Full-Time opportunity** based at our **expanding Upper Hutt manufacturing site **in** New Zealand**
- Opportunity to bring your skills and knowledge in **Quality Systems and programs related to compliance and product safety**
- Be part of our **collaborative team** where you will be **fully supported **with** comprehensive induction and training**

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

**What You Will Do**

The Quality Systems Specialist will support continuous improvement of our quality systems related to manufacture and supply safe biological products. This will leverage our company Quality and Compliance Excellence principals in relation to system and sub system ownership and inspection readiness.

You will play an active role in the ongoing improvement of quality systems and sub-systems performance, improving shopfloor GMP understanding and compliance, and to drive continuous improvement to enable reliable and compliant supply of safe biological products into local and overseas markets.

Of critical importance to the successful execution of this role is the ownership of non-product release related quality systems relating to product safety including complaints, stability, seed management, documentation and the managing of compliance programs including periodic product quality reviews, sample retention programs and real time trend analysis.

The Quality Systems Specialist role sits within the Quality organization and reports to the Site Quality Head.
- Responsibilities include, however not limited to:_
- Maintain and monitor Quality Systems and programs related to compliance and product safety to ensure compliance with regulatory and our company’s Animal Health Quality Management requirements such as personnel training, seed management, stability, equipment requalification, Qualifications and Validations, compliance of inwards goods release, Animal Health Quality Management compliance and document reviews.
- Develop and maintain stability, seed and sample retention programs, real time trend analysis in line with regulatory requirements and our company’s quality management requirements
- Performs quality review and administration of new and updated controlled documents.
- Effective complaint management, metric review, and product reviews. This also includes providing support to build effective quality systems.
- Provide metric reports as required for the compliance systems (e.g. deviations, CAPAs, change management, stability, customer complaints, seeds management etc.)
- General quality support, to include oversight for adherence to cGMPs, right-first-time completion of production GMP documentation, effective investigation/review of deviations and CAPAs and support for change management.
- Participate in product recall investigations and procedures as required by the business.
- May audit and evaluate current policies, procedures, and documentation for compliance with government laws, and regulations.
- Participate in auditing of company GXP related systems and processes.
- Perform internal and supplier audits and generate formal reports as required.
- Quality Management Sub-System Owner (e.g. Complaints, Personnel, Training, Seeds Management, Stability etc.) demonstrating detailed knowledge of the Quality Manual and site policy and procedures; Focus on continuous improvement through regular reviews and periodic feedback to the system owner; Proactive participation in preparation and execution of internal audits

**What You Must Have**
- Bachelor’s degree or higher in science-based discipline (such as chemistry, microbiology)
- Prior experience in a Quality Assurance/Control role in a technical capacity in a GMP/GLP environment
- Previous technical experience in reviewing method validation/verification, validation/qualification, and stability reports
- Understanding and knowledge of Quality Assurance (QA) systems, Good Laboratory Practice (GLP), Quality Control and Good Manufacturing Practice (GMP) Requirements
- Experience in Pharmaceutical industry is desirable, will also consider experience in food industry
- Previous auditing experience is desirable
- Attention to detail when reviewing technical and other documentation for accuracy and completeness; ability to ‘read for meaning’ and identify basic non-compliance issues
- Developing knowledge of processes involved in manufacturing, testing and distribution of product
- Excellent written and verbal communica

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