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Quality Control Lead

Jobref: IE_Tall_QCL
Location: Dublin
Salary: USD0.00 - USD0.00 per annum
Job Type: Permanent
Date Posted: Tue Nov 12 15:44:57 2019
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Role Purpose

This position reports to Tallaght Site Quality Leader, and will serve as the most senior Quality Control Leader for the Tallaght Site. The Tallaght Site Quality Control Lead will have overall responsibility to manage and control all QC activities (both chemical and microbiological) at Tallaght in accordance with identified quality standards and global Zoetis policies, as well as with all relevant regulatory and legislative regulations across the lifecycle of Tallaght Site products.

Direct and oversee analytical activities at third party contract laboratories and internally within Tallaght Site Laboratories, as appropriate. The QC Lead will provide a Leadership role in establishing the Quality Systems within the Laboratory; ensuring that Standard Operating Procedures are in place and that compliance with cGMP is maintained through ongoing training and process review. Ensure the implementation and on-going monitoring of Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) as applicable.

Ensure that all new Products manufactured at the site, Product transfers and QC projects to support manufacturing are adequately supported through Analytical Department activities in line with Zoetis Policies and Global SOPs requirements.

Ensure that the Analytical group operates in a cost effective and efficient manner and maintain an innovative approach for continuous improvement based on productivity improvement and implementation of best practices.

Role Responsibilities

  1. Provide analytical competence and technology to Tallaght Site organization so that all analytical methods are state-of-the-art and in compliance with regulatory expectations
  2. To coordinate and control the day to day operations of the Quality Control laboratory including but not limited to; providing a safe, secure and efficient working environment, ensuring all QC equipment is safely operated, all physical QC resources are maintained, stored and organised to allow efficient and effective operation, to control and direct all QC resources, operations and facilities in order to test all site materials from Raw Materials through to finished, Stability and Utility samples and to manage and direct a QC team of skilled based individuals through sound personnel practices such as: Performance management, Relevant and effective inductions, Identification of training needs, Coaching and Discipline.
  3. Responsible for developing, monitoring, implementing, and reporting on the operating budget and staffing plan; to monitor and report quality control progress, notifying any predicted shortfall or discrepancies against timescale and budgets.
  4. Immediate notification to the Site Quality Head of any Quality Control issues, and provide accurate and relevant information as required by the business.
  5. Direct and oversee analytical services performed at Tallaght Site and third party contract laboratories
  6. Oversee and direct the analytical method transfer for Tallaght Site products
  7. Ensure that analytical methods are adequately developed, validated, transferred and maintained
  8. Approve CMC documents related to analytical methods development & validations
  9. Develop and implement analytical method validation plans
  10. Ensure that adequate and timely analytical support for investigations (e.g. deviations, complaints) and troubleshooting is provided, where needed in conjunction with GMT, Opex, external 3rd party laboratories, and other involved Zoetis functions to minimize impact on product availability and sales
  11. To continuously review quality control processes, procedures and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements
  12. Ensure the adequate and timely qualification of contract laboratories using appropriate quality management tools to monitor and ensure third party lab compliance with Zoetis Quality Policies and applicable regulatory requirements on an ongoing basis e.g. QA Agreements, audits with appropriate follow up, risk assessments, Product Optimization action plans, performance indicators, follow up stability and product quality review.
  13. Actively manage the Quality Control Analytical team and set up their development and objective targets. They will mentor their team providing input and coaching on behaviours and professional development, will provide timely feedback; and evaluate performance of direct reports after obtaining the relevant functional input and evaluation.
  14. Assist Tallaght Site Quality department with preparation, management and follow up of internal audits and Health Authority inspections, as needed
  15. Review and monitor action plans for correction of audit observations related to the Analytical Labs and follow-up as appropriate.
  16. Utilize active thinking to generate creative solutions to complex technical problems
  17. Support the development of quality goals and targets as part of the organisation’s strategic plan
  18. Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean Lab methodology.

Candidate Requirements

Education & Experience

Technical Skills & Competencies

Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 65 years of experience in animal health, Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2018, the company generated annual revenue of $5.8 billion with approximately 10,000 employees. For more information, visit www.zoetis.com.