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Qualified Person (qp), Waterford, Teva Pharmaceuticals

Ireland, Ireland, Waterford
Published 2022-09-22
Expires 2022-10-22
ID #1178169746
Free
Qualified Person (qp), Waterford, Teva Pharmaceuticals
Ireland, Ireland, Waterford,
Published September 22, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Qualified person (qp)


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Description

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. Due to growth within the area, Teva are looking for additional Qualified Persons to join their team. We are looking at all levels from newly Qualified to Experienced QP’s to join our expanding area in our Waterford site. As Qualified Person, you will be responsible for ensuring that all products being released for commercial or for clinical trial purposes comply with the requirements of the Marketing Authorisation, or Clinical Trial Authorisation, have been manufactured according to the principles of GMP as per Directive 2003/94/EC A day in the life of our Qualified Person (QP) To ensure that all processes/stages in the manufacture, testing and packaging of products have been adhered to according to the cGMP/cGLP/Regulatory and licence requirements To ensure all batch related documentation is completed and endorsed by relevant trained personnel. To review and release batches according to shipment schedule ensuring all batches are in compliance with regulatory requirements. To identify and make recommendations for improvements to the process within the overall Continuous Improvement process of the Company. Outlining batch investigation requirements and responsibilities. Releasing batches as per scheduled shipment date (where possible). Ensure the principal manufacturing and testing processes have been validated. All the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records. Any planned changes or deviations in manufacturing or QC have been notified in accordance with a well-defined reporting system before any product is released. Such changes may need notification to and approval by the HPRA. Any additional sampling, inspection, tests and checks have been carried out or initiated as appropriate to cover planned changes or deviations. 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 QA/QC/Compliance role. Excellent knowledge of regulations and sources of regulatory information. Knowledge of Report Writing Experience of Accomplishing tasks through concern for all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; maintaining watchfulness over a period of time Authority to approve/reject product batches/materials or take other quality related decisions Experience of Review / approval of investigations into incidents/deviations Review / approval of Out-of-Specification investigations Ideally experience of Co-ordinating / being involved in recall decision Previous Experience as QP desirable but not essential Already [email protected]? 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 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

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    Registered on October 7, 2017

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    Manufacturing is the production of merchandise for use or sale using labour and machines, tools, chemical and biological processing, or formulation. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale. Such finished goods may be sold to other manufacturers for the production of other, more complex products, such as aircraft, household appliances, furniture, sports equipment or automobiles, or sold to wholesalers, who in turn sell them to retailers, who then sell them to end users and consumers.


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