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Qualified Person / Sachkundige Person (m/w/d)

Date: Jun 12, 2019

Location: Ulm, DE, 89079

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

Batch Release and Securing Quality

  • Batch Certificiation according  German AMWHV und Annex 16 EU-GMP Guideline for  medicinal products belonging to different dosage forms  (Tablets, Parenteralia, Patches, Liquids, Powder for solution, Creams, Aerosol ).
  • Assures GMP and Regulatory Compliance of the manufacturing and analytical processes for all pharmaceutical products supplied by Third Parties, where Ulm acts as Batch Release site
  • Ensures Quality of pharmaceutical products supplied by Third Parties taking in consideration Changes, Stability studies, Validation and Out of Trend Results.

Qualitätsprobleme / Quality Issues

  • Investigation and Assessment of „Out of Specification results“ and Deviations according the global Teva guidelines:
    • Internal communication and escalation  (NTM; gNTM; QUAM; MAC)
    • Lab Investigations, complex root cause investigation together with supplier
    • Risk Assessments
  • Initiation and Monitoring of Corrective Action
  • Autonomous evaluation of solutions for quality issues and process optimization in collaboration with MS&T and the Third Party Manufacturer

Collaboration with the Third Party Manufacturer (CMO)

  • In collaboration with the manufacturer the job holder interact with the supplier:
    • Ensuring  of supplier qualification
    • Ensuring of performing required investigations and risk assessments at the manufacturer in case of quality issues
    • Ensuring that international and Teva guidelines are followed in Transferprojects to avoid negative impact to the quality of the products.   
  • In collaboration with other stakeholders the job holder participates at the following tasks
    • Contract negotiations, Audits, Supplier Evaluation, Assessment of critical complaints from the market, supply service, launches of new products in time.

Product Quality Review / Annual Product Review

  • Assessment and Approval of PQRs
  • Initiation and Monitoring of Corrective Action at the Supplier / Manufacturer

Qualifications

  • More than 5 year experience in Quality Control / Quality Assurance
  • Approbation as Qualified Person according  German law (AMG §15)
  • Knowledge of international Guidelines, broad background of analytical methods and different manufacturing processes.
  • Participation at GMP Inspections
  • SAP and TrackWise experience
  • business fluent English and German

Function

Quality

Sub Function

Quality Assurance Methods

Reports To

Armin Leifick

Contact Person

Borbala Pap

Human Resource

0731 402 7779

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.