Global Quality Officer - Berlin, Deutschland - Inceptua

Inceptua
Inceptua
Geprüftes Unternehmen
Berlin, Deutschland

vor 2 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung

Global QA Officer

  • We are a pharmaceutical company, and the next generation partner to pharma, _
- biotech, and healthcare. We bring medicines to patients through clinical trial ser-_
- vices, and early access programs. We recognize that investing in talented people _
- creates value for our customers, our employees, our suppliers and the communities _
- in which we live and work. Our success is based on the motivation, dedication and _
- performance of our people. We strive to go the extra mile and achieve excellence in _
- all our services. _

We are hiring for the position of
Global QA Officer to be based in our office in
Windsor or Berlin for an immediate start.

You will become part of our global Quality Assurance (QA) Team and will be report
- ing to a Senior Global QA Manager based in UK. You will be working closely with
different internal functions to support Inceptua' s manufacturing, storage, and dis
- tribution activities for medicinal products mainly in EU but also world-wide.
As an experienced professional, you will independently plan, execute, and docu
- ment all Quality Assurance-related activities with focus on efficiency and the re
- quired level of detail to ensure the high-quality standards for the world-wide distri
- bution of clinical trial material, and unlicensed medicines in early access programs.

You will be able to contribute with innovative ideas to build and improve internal
structures in the changing environment of our growing organization.


Responsibilities include, but are not limited to:

  • Assist in maintaining and improving the Global Quality Management System
  • Initiate and support process optimization initiatives and revise SOPs
  • Qualify and requalify external service providers, customers, and suppliers for
  • GxP related and associated services
  • Prepare and conduct internal audits (selfinspections) to monitor and ensure
- compliance with GxP and internal quality standards
  • Process and assist with QA activities such as training programs, deviations,

- complaints and CAPA
  • Perform other duties as required by the business including representing the
QA department in activities for the Clinical Trial Supply & Services, and Early
Access business units

  • Execute the responsibilities according to lawful and ethical standards
  • Suggestions for improvement that benefit all employees with the QA depart
- ment and the entire Inceptua Group
  • Accomplish individual goals as per requirements determined by the Director,
Global QA


Your profile:


  • You hold a university degree in natural sciences (e.g., Biology, Biochemistry,
  • Pharmacy) or Quality Management
  • You have a minimum of 2 years' experience in a GxP environment
  • You have knowledge in and understanding of Quality Assurance tasks (e.g.,
supplier and customer qualification, deviations handling and CAPA) and GxP
- associated regulations (e.g., EU GDP Guidelines)

  • You are business fluent in English
  • You have a pragmatic Quality mindset
  • You have an overall company view and mindset and are a proactive team
player

Our company is home to employees from various backgrounds that speak a range
of languages. If you have a forward-thinking attitude and are ready to go the extra

Attachments must be in PDF format.
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