CareerAddict

QA Associate QMS - German, GMP

RM IT Professional Resources AG

Posted on Jun 4, 2025 by RM IT Professional Resources AG
Basel, Switzerland
Research
1 Jun 2025
Annual Salary
Contract/Project

QA Associate QMS - German, GMP vacancy for a globally operating Basel based company in the Pharma sector.

Your tasks:

  • Receives incoming documents (eg executed batch records, work orders, vendor labels, packaging instructions etc.).
  • Performs documentation in respective tools.
  • Prepares documentation needed for the batch record review (eg 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, eg 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 (eg CoC's, BRR Checklists).
  • Scan, file and archive documents owned by QA (eg 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.

Your experience/knowledge:

  • Technician or Bachelor (3 years experience)
  • Fluent in site language - German
  • English required (adequate knowledge oral & written)
  • 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.

Location: Basel, Switzerland
Work setting: Hybrid
Sector: Pharma
Start: 06/2025
Duration: 12months +
Workload: 80% - 100%
Ref.Nr.: BH 22861


Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are warmly welcomed, we will support you all the way.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.


Reference: 2959257110

https://jobs.careeraddict.com/post/104073652

This Job Vacancy has Expired!

RM IT Professional Resources AG

QA Associate QMS - German, GMP

RM IT Professional Resources AG

Posted on Jun 4, 2025 by RM IT Professional Resources AG

Basel, Switzerland
Research
1 Jun 2025
Annual Salary
Contract/Project

QA Associate QMS - German, GMP vacancy for a globally operating Basel based company in the Pharma sector.

Your tasks:

  • Receives incoming documents (eg executed batch records, work orders, vendor labels, packaging instructions etc.).
  • Performs documentation in respective tools.
  • Prepares documentation needed for the batch record review (eg 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, eg 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 (eg CoC's, BRR Checklists).
  • Scan, file and archive documents owned by QA (eg 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.

Your experience/knowledge:

  • Technician or Bachelor (3 years experience)
  • Fluent in site language - German
  • English required (adequate knowledge oral & written)
  • 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.

Location: Basel, Switzerland
Work setting: Hybrid
Sector: Pharma
Start: 06/2025
Duration: 12months +
Workload: 80% - 100%
Ref.Nr.: BH 22861


Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are warmly welcomed, we will support you all the way.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.

Reference: 2959257110

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