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Experte Qualitätssicherung / Qualified Person (f/m/x)

Job ID R0042745 Date posted Oct. 20, 2021 Location Vienna, Austria

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Job Description

Your Opportunity:

  • Approve authority / OMCL submission documents (final container, plasmapools)
  • Review of lot dispositions for bulk, final container and of finished goods as QP
  • Approve country CoAs (Certificate of Analysis)
  • Review lot specific documents before sending them to customers / authorities
  • Evaluate complaints and adverse events; approval of confirmed complaints
  • Approve donor exclusions, look back reports and post donation risk assessments
  • PQR
  • Establish and revise quality agreements
  • Evaluate of returned goods and exceptional cases
  • Support compliance of disposition process in terms of documentation issuing
  • Support and drive continuous improvement actions
  • Work in compliance with current SOPs, issuing deviations if necessary, issuing and updating of SOPs and forms
  • Authorized to sign for final batch disposition as well as authority / OMCL submission documents and batch
  • Authorized to approve lots for further manufacture and packaging under quarantine
  • Internal stakeholders: QA Disposition, QC, QA in Operations, MS, production, Supply Chain, Quality Systems, Regulatory Affairs, Visual Inspection, Finishing, Logistics
  • External contacts: Other Takeda sites (e.g. LE, LA, NE, ...) as well as CMO partners

Your Skills and Qualifications:

  • Degree in natural sciences (university, FH)
  • Working experience within a pharmaceutical or chemical industry in a quality-related role is highly beneficial
  • Practical experience in Quality Management and thorough knowledge of GMPs
  • Education and Certification as Qualified Person according to §7 AMBO 2009 or at least pre-condition (educational background and expertise in QA/QC) to comply with the requirements very soon
  • Self-reliant and accurate working personality, who is willing to take responsibility
  • Very good judgement based on regulations and Quality Management System
  • Flexible and well-organized attitude
  • Focus on the few priorities that matter most and delivers superior results
  • Ability to work under pressure and to keep track of tasks and priorities
  • Experienced team player attitude
  • Excellent communication skills in order to interface with external and internal partners
  • Profound knowledge of computerized systems (MS Office, ERP, SQL*LIMS)
  • Very good language skills in German as well as in English

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work! Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work – life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 3 389,68 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.


AUT - Wien - Industriestrasse 67

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Full time