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Qualified Person - Quality

Date: Apr 6, 2021

Location: Waterford, IE, X91

Company: Teva Pharmaceuticals

Who are we?

 

We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. Yet until today, you may not have heard of us.

 

We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.

 

We would like to invite applications for the role of Qualified Person on a permanent contract. As Qualified Person, you will be responsible to ensure that that all products released for commercial or for clinical trial purposes comply with the requirements of the Marketing Authorisation, or Clinical Trial Authorisation. You will ensure all products manufactured according to the principles of GMP, as per Directive 2003/94/EC.

A Day in the Life of our Qualified Person

 

  • To ensure that all processes/stages in the manufacture, testing and packaging of products has been adhered to, according to the cGMP/cGLP/Regulatory requirements.
  • Develop and improve quality systems by identifying areas for improvement (NVAA’s and key variances) and take corrective action as required to ensure continuous improvement in accordance with Company Continuous Improvement Process.
  • Review change proposals and related documentation for compliance with Regulatory approvals and GMP requirements.
  • Ensure that all work carried out is in compliance with the required standards conforming to company, cGMP, cGLPs, SOPs, regulatory regulations and guidelines, H & S and Environmental guidelines.
  • To review and approve batch documentation, investigation reports, change controls, QRMs, SOP’s and qualification reports, ensuring they are completed right first time and in full in accordance with Good Manufacturing Practice requirements.
  • To review and release batches according to shipment schedule ensuring all batches are in compliance with regulatory requirements.

Who we are looking for?

 

Are you….

 

• Qualified Pharmacist or Graduate of Diploma in Pharmaceutical Manufacturing Technology or equivalent “Qualified Person” status as defined by E.C. Directive 2001/83

 

Do you have….

 

  • Proven experience within the Pharmaceutical industry in a leading QA/QC/Compliance role.Broad Knowledge of Analytical Techniques and Experience in HPLC
  • Excellent knowledge of regulations and sources of regulatory information.
  • Experience of Inhalation Devices will be an advantage.
  • Understanding of Production and Laboratory systems to effect judgement decisions consistent with business needs.
  • Strong Team Building and Communication skills
  • Excellent planning and organisational skills to ensure workload prioritisation and schedule adherence.
  • An understanding of internal/external customer requirements and an ability to respond promptly to needs.
  • Ability to work on own initiative to meet and exceed business objectives

Teva’s Equal Employment Opportunity Commitment

At Teva, we pride ourselves on being a company where we can all thrive, and where everyone feels comfortable being their true self.

Diversity and inclusion sits at the heart of everything we do. By valuing difference, we can be a better employer for our colleagues, and provide a better service for our customers and patients. That’s why we’re constantly looking for ways in which we can learn from each other, embrace what makes us unique and contribute to a fairer society free from discrimination and prejudice