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Vor 7 Tagen

QA Associate (m/w/d)

QA Associate (m/w/d)

K-Recruiting GmbH

Personaldienstleistungen und -beratung

  • Basel
  • Vollzeit
  • 55.500 CHF – 110.500 CHF (von XING geschätzt)
Vor Ort

QA Associate (m/w/d)

Über diesen Job

QA Associate (m/w/d)

7 Monate

Tasks :

  • Receives incoming documents (e.g. executed batch records, work orders, vendor labels, packaging instructions etc.). Performs documentation in respective tools. Prepares documentation needed for the batch record review (e.g. Analysis Reports, Specifications for clinical development, country label approval etc.).

  • Support the timely release of GMP batches of labels, primary packed materials and Investigational Medical Products.

  • Review and approve GMP relevant documents, e.g. work orders, packaging master documents, clinical study labels,... Batch record review for both packed material from internal or contractors. Compiles, Notifications of Extension to be issued due to revised expiry dates. GMP relevant documents in own area of responsibility (e.g. CoC's, BRR Checklists).

  • Scan, file and archive documents owned by QA (e.g. Certificate of Compliance, Batch Record Review Checklists).

  • Write and review procedures and forms related to the QA Batch record Review Process.

  • Contributes to Right First Time performance reports for release of IMPs.

  • Supports and collaborates with QA & GCS Line Unit in process improvements, Quality & Compliance issues and in the use of GMP relevant IT tools and processes.

  • Support the use, improvement, evaluation and implementation of GMP relevant IT tools and processes

Qualification:

  • Technician or Bachelor ( 3 years’ experience)

  • Languages:

  • Fluent in site language German

  • English required (adequate knowledge oral & written)
    Experience/Professional requirement:

  • Communication skills to sufficiently address GMP and logistic related questions with line unit experts.

  • Scientific, technical and regulatory knowledge in a specific area. Basic knowledge of drug development.

  • Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines

  • Good organizational skills.

Start : 01.06.2025

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Unternehmensdetails

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K-Recruiting GmbH

Personaldienstleistungen und -beratung

51-200 Mitarbeitende

München, Deutschland

Bewertung von Mitarbeitenden

Vorteile für Mitarbeitende

Flexible Arbeitszeiten
Home-Office
Kantine
Restaurant-Tickets
Kinderbetreuung
Betriebliche Altersvorsorge
Barrierefreiheit
Gesundheitsmaßnahmen
Betriebsarzt
Training
Parkplatz
Günstige Anbindung
Vorteile für Mitarbeitende
Firmenwagen
Smartphone
Gewinnbeteiligung
Veranstaltungen
Privat das Internet nutzen
Hunde willkommen

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