Batch Record Reviewer

Discipline: Biotechnology
Job type: Temporary/Freelance
Contact name: Gemma Dozy

Contact email: g.dozy@panda-int.com
Job ref: 13658
Published: 28 days ago

At the moment I am looking for a Batch Record Reviewer for one of my biotechnology clients in Switzerland. This regards an initial 6 months contract, however the project will run several years, so extension is expected.

 

 

Responsibilities:

  • Review of the Executed Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures, raw data, logbooks)
  • Support batch release by ensuring the completeness of the documentation package
  • Review comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
  • Support the initiation of deviations and investigations for Batch Record review related observations
  • Collect and evaluate on a regular basis KPI data
  • Write and revise SOPs in his/her area of expertise

 

Profile:

  • Bachelor degree or equivalent
  • Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage
  • Ability to identify non-compliance and gaps from quality standards
  • Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
  • English good command is required

 

 Start date

 

  • Preferably September or October, November also possibl

 

Interested?

 

If you’re interested in the above description, please apply with your CV by clicking on the ‘apply’ button. For further information, please contact Gemma Dozy at +31 (0)20 20 44 502 or by email at g.dozy@panda-int.com