QA Manager 100% (w/m/d) at Arcera
Berlin, Berlin, Germany -
Full Time


Start Date

Immediate

Expiry Date

17 Jan, 27

Salary

90000.0

Posted On

19 Oct, 26

Experience

4 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical Manufacturing

Description

 

QA Manager 100% (w/m/d)

 

Major Accountabilities:

 

  • Review and approval of GMP and GDP related documents (e.g. MBRs, Certificates of Analysis, deviations, artworks)
  • Support of the Qualified Person (QP) in batch release preparation, including document provision, review, and preparation, batch record review, as well as maintenance and continuous improvement of related systems.
  • Management, coordination and follow-up of change controls, complaints, deviations, CAPAs and Events in the eQMS, ensuring timely completion and GMP-compliant execution
  • Continuously drive improvement of our quality assurance systems 
  • Review and update of documents (e.g. SOPs, certificates of analysis, specifications, SMF) 
  • Represent the company in inspections by authorities and provide support as well as follow-up of observations 
  • Responsible for the archiving of documents as well as for the storage and management of retained samples 
  • Support other team members as required
  • Compile and lead communication with suppliers and service providers 
  • Support in administrative and organizational activities 
  • Administration of the GMP training in electronic learning management system
    • Coordination, preparation, and review of Product Quality Reviews (PQRs)

 

Your Profile:

 

  • Master’s degree in Life Science, preferably in Pharmacy or Pharmaceutical Sciences  
  • 3-5 years of experience in pharmaceutical industry preferably in Quality Assurance or Quality Management
  • Excellent planning and organizational skills with capability to prioritize tasks and adhere to timelines highly required 
  • Prompt and accurate performance of tasks and responsibilities 
  • Structured and quality-conscious way of working  
  • Able to work in an international and interdisciplinary environment 
  • Team player with good communication and negotiation skills 
  • Target oriented, multi-tasking and able to work under pressure 
  • Fluent in German and English, with excellent written and verbal communication skills

 

We offer a very attractive working environment within a highly motivated team with excellent working conditions. You can expect the following benefits:

  • A position with a stable and resilient pharmaceutical company
  • An international working environment within a continuously growing organization
  • Interesting and highly diverse responsibilities that provide a strong foundation for further career development in the pharmaceutical industry
  • An attractive salary package
  • Complimentary coffee, tea, and fresh fruit
  • Attractive additional benefits, such as corporate benefit programs


Responsibilities
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