Quality Assurance Lead

Job Description

Quality Assurance - Lead Technician (FPU/FPP Release)

• Permanent full-time role with competitive remuneration and benefits

• Location: Wellington - Upper Hutt New Zealand

• Grow your QA leadership career in a successful expanding industry

• Lead critical QA activities for FPU/FPP release in a global Animal Health manufacturer

• Be the go-to expert for batch documentation product release and continuous improvement

What You Will Do

Responsibilities include however not limited to:

You will play a key role in batch documentation product release and quality systems helping ensure timely supply of high-quality products.

Batch Documentation

Ensure batch documentation is available and compliant to meet production and testing schedules by:

• Providing backup for QA / Senior QA Officers in issuing batch documents and test worksheets allocating expiry dates and completing SAP transactions

• Monitoring department KPIs and supporting action plans with the Quality Assurance Manager

Driving continuous improvement by providing subject matter expertise in QA systems such as:

• Batch review and disposition

• Document control and archiving

• GMP training systems

• Internal auditing

• Change control and deviation management

• Right First-Time and other quality improvement programs

Product Release
Support timely and compliant product release by:

• Providing backup for QA / Senior QA Officers in reviewing batch/test documentation for accuracy completeness and compliance and facilitating corrections with other departments

• Performing second quality review of Solution Antigen Bulk Antigen and Blend batch records

• Releasing Antigen Blend and packed product batch records

• Reviewing and approving market documents for export and ensuring release documentation meets export schedules

• Providing batch disposition for temperature excursions

• Approving revalidations of Antigens and Pack-at-Risk

General Documentation & Compliance

• Generate review and maintain all documentation in line with company and relevant quality standards

• Ensure all production-related batch and inventory records are accurate and complete

• Define processes and drive improvements through updated standards and training

• Follow global and local procedures for reporting Adverse Events and Product Quality Complaints within required timelines

Deviations & Change Management

• Review and approve deviation closures including supporting documentation

• Use root cause analysis to define appropriate Corrective and Preventative Actions (CAPAs)

• Assess compliance risks for impacted products and recommend product disposition

• Approve events following completed batch disposition

What You Must have

Education

• Bachelors degree or higher in a science-based discipline

Certifications

• Qualified Lead Auditor (desirable)

Experience & Skills

• Strong understanding of QA systems GLP and GMP requirements in a production environment

• Extensive prior experience in a similar role in a GMP/GLP manufacturing environment ideally in the pharmaceutical industry within Quality Operations or similar manufacturing role

• Demonstrated experience in more than one biopharmaceutical function (e.g. manufacturing technology validation engineering quality analytical)

• Excellent written and verbal communication skills with the ability to positively influence others

• Proven ability to work collaboratively to resolve complex problems

• Demonstrated leadership and ability to build strong relationships and alignment with key stakeholders

• Logical structured approach to problem solving

• Strong planning and organisational skills with the ability to meet deadlines

What You Can Expect

• A pivotal QA role where your decisions directly support safe reliable product supply

• Autonomy to manage your work with strong support from a trusted global-leading Animal Health organisation

• Clear opportunities to upskill cross-train and progress your QA career

• Exposure to quality systems and projects that broaden your technical and leadership capabilities

• A collaborative team of experienced QA and Operations professionals who value knowledge sharing and continuous improvement

We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer committed to fostering an inclusive workplace.

Required Skills:

Preferred Skills:

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