Technical Writer (GMP documents)

For one of our clients we are looking for a Technical Writer (GMP documents).

  • Do you have a higher vocational education or BSc in biological, medical-technology or pharmaceutical sciences ?
  • Do you have a minimum of one year experience in writing GMP documents?
  • Do you have experience with cells?

Then, you might be the candidate we are looking for !

Job Description 

Would you love to be a part of a multi national, multi lingual team in the field of personalized medicine in first class service to our many and expanding customers? Are you interested in working in world class scientific services? Are you looking for a new role that gives you something new to do every day?

This may be just the job for you...

Responsibilities 

Responsible for drafting and/or reviewing Technical documents including batch records and for manufacturing processes tech transfer protocols.

Delivery of services in this role will include, but not be limited to:

  • To gain full understanding of a new process in details and transfer this knowledge to technical documents. e.g. manufacturing batch records
  • To improve manufacturing batch records and instructions in regards to quality and safe aseptic handling
  • To draft and/or review manufacturing related documents including, Mat specifications, technology transfer related and aseptic handlings related protocols and reports if assigned by the manager.
  • To collaborate with MSAT associates on creating a timeline for completion of GMP documents
  • To train manufacturing team on the drafted batch records
Profile 

You should have the following experience/knowledge :

  • Higher vocational education or BSc in biological, medical-technology or pharmaceutical sciences
  • Minimum of one year experience in writing GMP documents is a must
  • Experience in GMP and aseptic handling manufacturing is highly desirable
  • Experience in working with cells is a must
  • Strong planning and follow up skills
  • GMP knowledge, Quality awareness and in-depth knowledge of house procedures
  • Strong communication skills in English both verbal and written.
  • Accuracy, tidiness, planning skills, attention to details and time management skills.
Contact Information 

Claire Aerts
+32 15 21 11 04
claire.aerts@valesta.com

Application form : Technical Writer (GMP documents)

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

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