QA System/Incident Coordinator (m-w-d)

Ort: Berlin, Deutschland
Gehalt: verhandlungsfähig
Spezialisierungen: Qualitätssicherung
Vertragsart: Arbeitnehmerüberlassung
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Aktuell bin ich für ein pharmazeutisches Unternehmen auf der Suche nach einem QA System/Incident Coordinator (m-w-d) in Berlin:

This position will be shared between two department: QA system and QA incident teams The Coordinator will be responsible for:

  • Day-to-day operations of the document control programs, including the document revision process, record archival. He will also support other Quality Management System initiatives as opportunities arise.
  • The management of deviations and/or complaints related to third-party contractors (e.g. manufacturers, service providers) which EM is responsible for.

Major Responsibilities: Based on business need entails the following tasks:

For QA system activities:

  • Coordinate and maintain the Documentation programs, to ensure patient safety, product quality, and overall compliance, within the context of a virtual sponsor/business partner environment. These responsibilities include but are not limited to:
  • Coordinates changes to the applicable Quality System procedures by reviewing changes for applicability, interfacing with internal approval SMEs and management, facilitating functional meetings, and acting as a liaison to bring documentation to closure.
  • Provide basic guidance and training to site users in QS processes.
  • Support in Site inspection preparation and response process.
  • Performs data entries in applicable systems as required to maintain the processes, e.g. Supplier Management, Compliance Management
  • Advises and responds to queries on quality systems.
  • Records and follows-up on all quality system entries.

For QA Incident activities:

  • Coordinates deviations from third-party contractors in the context of manufacturing of APIs, bulk, intermediates, final drug products including quality control, medical devices or transportation.
  • Supports resolving deviations related to product release. Must use scientific judgment to ask key questions during investigations intended to identify root cause of issues.
  • Coordinates and assesses (root cause, impact/risk assessment) product technical complaints, ensure timely completion of the investigation statement in the complaint database.
  • Supports resolving quality problems (root cause investigation) and implementation of CAPAs. Tracks timely closure of CAPAs.
  • Adhere to all GMP requirements

Qualifications (Education, skills, experiences and personal characteristics necessary for success in this position):

  • Master's degree in science or equivalent is required; Biology/Chemistry preferred, with 1-3 years of experience in the biotechnology, pharmaceutical, (GxP) industry; or equivalent combination of education and experience.
  • Experience in Quality Assurance functions and Quality Compliance functions preferred.
  • Good written and verbal communication skills required.
  • Must be fluent in English. Other languages a plus.
  • Scientific writing experience preferred.
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
  • Strong customer service philosophy required.

Diese Stelle ist interessant für Sie und Sie erfüllen die wesentlichen Voraussetzungen? Dann senden Sie Ihren Lebenslauf direkt über den Link auf der Webseite z.H. Herr Kevin Hohl oder direkt an k.hohl(at)realstaffing.com

Fragen zur Stelle beantworte ich gerne unter +49 (0) 69 264 89 8075.

Falls nicht, freue ich mich über Kontakte aus Ihrem Netzwerk, für die diese Vakanz interessant sein kann.

Ich freue mich auf Ihre Bewerbung!

Kevin Hohl

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