Qc Manager

7 days ago


Auckland City, New Zealand Elanco Full time

Education : EQUIVALENTEXPERIENCE

**As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.**

**Functions, Duties, Tasks**:

- Manage Quality Control Department staff through performance and learning & development programs to align with site KPIs and provide opportunities for continued staff education. Lead HSE behavioral change throughout the Quality Control Department to ensure compliance with Elanco HSE requirements and local HSE legislation including, but not limited to, PPE requirements, dangerous goods & chemical storage and working with hazardous substances (HSNO).
- Manage and maintain the Quality Control Department according to GLP and GMP requirements by providing guidance, training and support to Team Leaders and staff in GLP & GMP related operational requirements, including Quality Control testing, implementation and maintenance of test reference standards, instrument/equipment qualification, calibration & maintenance and analytical test method validation. Ensure all staff are qualified, trained and assessed in their roles. Assist the Quality Assurance team with site GMP training & internal audits as required.
- Manage all Quality Control microbiology and analytical chemistry activities, including inwards goods processing, environmental monitoring, sterility testing, out-of-specification investigations, compendia updates, to ensure the timely release and availability of raw materials, packaging components and in-process checks for scheduled operational requirements.
- Manage the schedule for finished products testing, including external contract testing laboratories, to ensure the timely release of results and to reduce lead times for product release.
- Manage and reduce Quality Control activity related costs including consumable costs, external testing costs, instrument/equipment downtime costs and costs associated with testing performance such as repeat testing and the use of suboptimal instrument/equipment in delay of results.
- Collaborate with Technical Department to review validation activities including media fills and cleaning and Product Maintenance Activities such as ongoing and accelerated stability trial requirements.
- Collate and review monthly Quality Control Department metrics, including but not limited to, the number of samples tested, the number of tests performed, out-of-specification investigations performed, number of repeat tests.
- Manage the retention sample storage areas and stability chambers to ensure compliance with GMP and HSE requirements.

**Minimum Qualification**:

- A recognized tertiary degree in a chemistry discipline.
- A minimum of 5 years laboratory experience in a chemistry laboratory preferably in the pharmaceutical/veterinary or related industry, including management experience of large teams.
- Detailed knowledge of chemical analyses especially HPLC, instrumental and wet chemistry techniques with ability to provide support and guidance to direct reports when resolving technical issues.
- In-depth knowledge of cGLP/cGMP and local/global Regulatory and Pharmacopoeia requirements for laboratory operations.
- Strong technical writing and review skills with ability to provide clear, unambiguous instructions.
- Strong problem-solving skills, including out-of-specification investigations in a Quality Control laboratory.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status


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