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Quality Control Lead

Wednesday, may 20, 2020
Description

Why work for this company?

Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.

Company Profile:

65+ years of experience in animal health.
Nearly $6 billion annual revenues.
25 manufacturing sites around the world.
10,000 employees worldwide of which 1,100 employees are committed to R&D.

Responsibilities:

* provide analytical competence and technology to Rathdrum Site organisation so that all analytical methods are state-of-the-art and in compliance with regulatory expectations
* 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 API
* 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

* 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.

* immediate notification to the Site Quality Leader of any Quality Control issues and provide accurate and relevant information as required by the business
* partner with the Quality Operations Lead to ensure alignment with planning and scheduling requirements, operational needs and implementation of OPEX and Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology
* partner with QSS and Compliance Lead in support of implementation of Quality Systems and Inspection Readiness including internal and Health Authority Inspection
* direct and oversee analytical services performed at Rathdrum Site and third-party contract laboratories
* oversee and direct the analytical method transfer for Rathdrum Site products
* ensure that analytical methods are adequately developed, validated, transferred and maintained
* approve CMC documents related to analytical methods development & validations
* develop and implement analytical method validation plans
* 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 functions to minimise the impact on product availability and sales
* to continuously review quality control processes, procedures and capabilities in order to sustain the most cost-effective and efficient methods for meeting quality requirements
* ensure the adequate and timely qualification of contract laboratories using appropriate quality management tools to monitor and ensure third party lab compliance with Quality Policies and applicable regulatory requirements on an ongoing basis e.g. QA Agreements, audits with appropriate follow up, risk assessments, Product Optimisation action plans, performance indicators, follow up stability and product quality review
* 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 behaviors and professional development will provide timely feedback; and evaluate performance of direct reports after obtaining the relevant functional input and evaluation
* review and monitor action plans for correction of audit observations related to the Analytical Labs and follow-up as appropriate.

Education:

* Bachelor of Science in Chemistry with +15 years of quality control and analytical laboratory experience and proven demonstrated experience in leading a QC team
* Minimum of 15 years PROGRESSIVE experience in the quality control, quality assurance, manufacturing function of veterinary or human API products with prior roles at Manager Level in a Quality/Technical Manufacturing environment an essential pre-requisite
* Recognised Lean Six Sigma Qualification (Green Belt or Black belt)
* Training & Experience at the application of Change Execution Methodology

Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003


Job Reference:QCL1000
Position Type:Permanent
Sector:Biotechnology & Pharmaceutical, pharmaceutical
Working Hours:Full-Time
Location:Wicklow, Wicklow, Ireland
Salary:Dependent on Experience
Contact:Randstad Financial & Professional, Randstad Financial Services, London, United Kingdom
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