Senior Associate QA

For our client in Breda, we are looking for a Senior Associate QA.

The perfect candidate has at least:

  • An EU Pharmacist degree (or equivalent) 
  • Preferably 0.5 year of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations. 
  • Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases. 
Job Description 
  • Act as the first point of contact in case of production queries (quality related) during packaging and labeling operations. Work together with production and maintenance team to resolve the quality related problems. 
  • Review and approve class I Non-Conformances 
  • Review and approve batch record exception reports 
  • Coach production and maintenance staff to improve quality and to limit the number of errors 
  • Perform finished product checks during (commercial) production runs 
  • Complete batch release preparation prior to Qualified person disposition. 
Profile 

The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent. 

Minimum Requirements 

  • EU Pharmacist degree (or equivalent) is required (e.g. BIG registered) 
  • Preferably 0.5 year of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations. 
  • Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases. 
  • Manufacturing and/or Quality analytical processes and operations. 
  • Fluent in English language. 

Systems 

  • TrackWise (NC/CAPA) 
  • SAP 
  • MS Office (Word, Excel) 
  • Werum PAS-X (electronic batch Records) 

Skills 

  • Analytical 
  • Work independent 
  • Hands-on and result driven 
  • Team player 
  • Strong communication skills 
  • Excellent in English 
  • Quality mindset 

***Note: This job is 5 working days (mon-fri), in 3 shift operation 
- Early: 0630-1500 every other week 
- Late: 1430-2300 every other week 
- Night: 2230-0700 for now every 8 weeks (not first 3 months) 

Contact Information 

Linda Strijkveen
+31 20 757 06 25 
linda.strijkveen@valesta.com 

Application form : Senior Associate QA

Files must be less than 3 MB.
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Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.

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