Documentation Compliance Specialist

Amsterdam Pharmaceutical Temporary/Freelance 29.11.2018

Our client who is a leader in the bio pharmaceutical industry is currently looking for a QC Documentation Compliance Specialist for their Method Validation department.

Our client who is a leader in the bio pharmaceutical industry is currently looking for a QC Documentation Compliance Specialist for their Method Validation department.

Your key responsibilities within the project support department will be to assess and keep up to date specific documentation with respect to the most recent Pharmacopoeia (Ph. Eur and USP). The main objective is to improve the efficiency and logical flow of documentation.

 

RESPONSIBILITIES

  • Setting up and maintaining documentation databases (protocols and reports).
  • Coordinating and reviewing validation protocols and reports for compendial methods that are outsourced to third parties.
  • Serve as the contact person for external laboratories
  • Manage complaints with subcontracted work.
  • Proactive participation in the Material Review Committee of SPP and the execution of activities resulting from it.
  • Conduct and process periodic assessments
  • Analysis certification, Specification sheets of raw materials, packaging materials and end products, and Method documents.
PROFILE
  • HBO degree
  • Experience in the pharma industry
  • Knowledge of GMP, Pharmacopoeias, QC analysis methods (chemical and microbiological)
  • Knowledge of ICH validation guidelines
  • Experience with writing/reviewing validation protocols
  • Working knowledge with LIMS and Trackwise
  • Work well independently
  • Good command of Dutch and English
PROJECT START DATE

ASAP

PROJECT DURATION

6 months - with possible extension
 

 

INTERESTED?

If you’re interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below.

Ps: Did you also know that we offer a generous referral scheme because great people know great people, right!

For further information, please contact Anita Gashi at +31 (0)20 20 44 502 or by email at a.gashi@panda-int.com

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