Job Description

• Exciting Permanent Full-Time role with an innovative global Animal Health business.
• Your opportunity to lead and drive the Quality and Continuous Improvement culture within the business.
• Serve the highest standard of supplying “Zero Defect Product” to the customers. Bring your innovative streak, curiosity, and learning spirit into a career of purpose and personal growth.

Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global 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.
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.

ENSURING THE QC TEAM STRUCTURE, TRAINING, SKILL LEVEL AND RESOURCES ARE APPROPRIATE FOR THE DEMANDS OF THE SITE AND ITS GLOBAL MANUFACTURING FOCUS.

• Participate in the interview process for new staff. Ensure that the required initial and continuing training of all department personnel is carried out and adapted according to need, for GMP compliance.
• Achieve continuous improvement in QC group activities through leadership directed toward resource, utilisation and cost review, along with participation in process and profit improvement programmes.
• Maintain team focus through regular objective setting and performance review using company approved process.
• All performance issues to be confronted in a timely and positive manner that seeks permanent resolution as its goal. Set and manage annual budget and track through Rolling Forecast (RF) and accrual process.

WHO WE ARE

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our Company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

ROLE OVERVIEW:

The Quality Control (QC) Manager is responsible for ensuring that quality control testing is completed to meet planned production requirements and that the testing programme and inwards material release process meets the requirements of defined regulations, compendia, registered methods and specifications.
Quality Control (QC) test results form part of the basis for product release. Laboratory management is segregated into chemistry testing, release of inwards goods (raw materials, third party manufactured products, packaging and labels), external chemical testing (QC contract laboratories), immunology and microbiological testing; sterile support services (QC Media Kitchen); and external microbiological and large animal testing (QC contract laboratories).

WHAT WILL YOU DO:

The QC group functions within the Quality Operations at Upper Hutt. The department’s scope covers the chemical, immunological and microbiological testing aspect of in-process samples, final products, release of inwards materials and third party manufactured finished products. This requires routine testing within agreed time schedules as well as non-routine testing work (e.g. reagent validation, changes to primary packaging etc.). Technical evaluation of routine test results is expected along with evaluation and participation in test validation projects. The QC Manager is expected to lead or be an integral member of these projects.

IN THIS ROLE , YOU WILL BE RESPONSIBLE TO ENSURE THAT:

• Systems are in place to ensure planned testing is completed on time. Maintain BOMs relating to Quality Control tests. Data generated from tests to be reliable and accurate. All test data and validation to be documented according to site standards.
• All SOPs are current and are followed in actual practice. All staff are trained in test procedures appropriately.
• All tests impacting on site are adequately validated and meet Corporate and Regulatory Compliance requirements.
• All reagents/media used in assays are suitably validated. Equipment are qualified and calibrated in accordance with site procedures.
• Receive the handover of new tests and the transfer of tests from other facilities through the correct protocols.
• Ensure all test data is reviewed for completeness and GMP compliance. Testing / releasing raw materials, primary packaging and third party manufactured finished goods in a controlled manner according to written specifications.
• Quarantining or rejecting non-compliant raw material, primary packaging and third party manufactured finished goods. Perform external audits on contract testing laboratories and vendors.