Specialist QA (m/w/d) für Quality & Records

Für unseren renommierten Kunden aus der Pharmaindustrie in Biberach suchen wir ab sofort:

Specialist QA (m/w/d) für Quality & Records

Ihre Aufgaben

  • Process external deviations and OOX results initiated by external partners (CMO, CL, Service Providers) in compliance with regulations and BI internal procedures.
  • Enter information about external deviations / OOX results in the database
  • Assess external deviations and coordinate the investigation and CAPA in alignment with the Team Member Quality as needed
  • Coordinate deviation / investigation related activities and present the results to the key personnel at BI
  • Support and advice functional departments during processing of deviations, investigations and CAPAs
  • Represent the interface between functional departments, pharmaceutical key personnel as well as subject matter experts and external partners
  • Contribute to the optimization and development of the process and the supporting IT system for Deviation / Investigation / CAPA Management
  • Present deviations during inspections
  • Generate KPIs, overviews and trend reports related to external deviations
  • Supports the qualification process of external service and material suppliers by contributing to the creation and maintenance of Quality Assurance Agreements and collection of documents and performing data entry in the corresponding electronic database.

Ihre Qualifikationen

  • Bachelor or Master degree with focus on natural science (e.g. Pharmaceutics, Chemisty, Biology or Biotechnology) or Professional Training with several years of experience in the pharmaceutical industry in a GMP regulated area (e.g. Quality Assurance)
  • Several years of experience in the pharmaceutical industry in a GMP regulated area
  • Knowledge and hands-on experience gained in GMP regulated environments in pharmaceutical development or production or quality control or quality assurance for 3-4 years.
  • Experience in development and manufacture of pharmaceuticals, biopharmaceuticals or ATMPs would be beneficial.
  • Knowledge of international regulatory guidelines (US, EU, ICH) and quality standards for human pharmaceuticals including respective development activities and data handling.
  • Knowledge of quality and risk management tools would be beneficial.
  • Well organized and structured working approach
  • Good communication and presentation skills
  • Fluency in written and spoken English and German.
  • Proficient in the use of personal computers.

Wir freuen uns auf Ihre Bewerbung und auf eine gute, vertrauensvolle und erfolgreiche Zusammenarbeit!

Gewünschte Bewerbungsarten

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  • persönlich

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Frau Poser

Telefonnummer: +49 (73 51) 82 98 63 29

apero GmbH
Marktplatz 1
88400 Biberach an der Riß