Loading...
Share this Job

Qualified Person

Date: Aug 26, 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

Function

Quality

Sub Function

Manufacturing Quality Assurance

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.