QA Compliance Manager / no-231

Status: 
closed
Location: 
Stein
Start Date: 
2019-02-01
End Date: 
2019-11-30
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
1.728
Assignment: 

Background

 

For our customer located in Basel/Stein/Switzerland we are currently looking for (m/f) a QA Compliance Manager

  • Type of placement:  10 months, external contract with possible long term extension
  • Company:  major Pharma company in Stein area
  • please ask us for the exact rate Range

 

Accountabilities

  • Supports project activities as member of QA Compliance for activities related to qualification / validation of equipment, utilities and facilities and associated change controls activities 
  • o Review and approve Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations 
  • o Review and approve Cleaning Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations 
  • o Review and approve Equipment, Facility and Utilities Qualification Protocols, Reports and associated documents including Risk Assessments and Deviations 
  • o Perform Quality risk assessments in case of critical deviations and initiate escalation process if applicable 
  • Supports project activities as member of QA Compliance for activities related to Quality Management System 
  • o Writes / Reviews / Approves SOPs/Forms/reports associated with above duties and provide support for creation, maintenance and retirement of GMP related documentation in the respective databases (e.g. Sharepoint) 
  • o Prepares training modules for QA Compliance and C&GT Stein 
  • Adheres to HSE guidelines and requirements 
     
Requirements: 

Candidate profile

  • Education: (minimum/ desirable):
  • A university or academic degree in Engineering, Chemistry, Pharmacy, Biology or equivalent. 

Language

  • Relevant Experiences: Professional in German and English (spoken and written). 
  • Professional experience in QA / QC, Engineering, Production; very good GMP knowledge, experience of minimum 5 years in the pharmaceutical industry (sterile / biotechnology / C&GT a plus) or comparable experience in other industries.

 

Kindly be informed that this job offer  is from our customer in Switzerland. Therefore we can only accept applications within the EU or applicants with Swiss work permissions.  
Please attach your CV in Word format. 
SimplyVision is looking forward to your application.