Posted to MedZilla on 9/21/2017


ProClinical

Netherlands, QA Specialist/ QP Qualified Person QA_OB_13380-MZ


 
 

Our client, a well-known pharmaceutical manufacturer, is currently seeking a QA Specialist to join them at their site in Breda. The successful candidate will be either a Qualified Person (QP) or a Responsible Person (RP).

Main tasks:

  • Provide daily oversight, guidance and support to Production staff in regards to compliance with Quality Policies and Procedures.
  • Disposition batches labeled and packaged at ABR
  • Handle Non Conformances and CAPA's mainly as initiator or QA-contact. Lead and assist in various investigations as needed.
  • Own, review and approve SOP's
  • Handle change control records mainly as assessor or as QA contact
  • Participate in ABR projects and improvement efforts including product launch teams
  • Partner with Production staff in performing risk analysis and the establishment of quality limits and requirements.
  • Perform GMP compliance checks in production
  • Assist in development and delivery of GMP training activities for QA- and production staff.

Minimum Requirements

  • EU Pharmacist degree (or equivalent) is required (e.g. BIG registered)
  • Typically 3+ years of related professional experience Relevant experience in dealing with Non Conformances and Change Control records
  • Good problem solving skills
  • Sound knowledge of Good Manufacturing Practice and Good Distribution Practice

Preferred Requirements

  • Experience in (bio)pharmaceutical production environment, in particular packaging and labeling
  • Customer oriented and service minded

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on +44 203 8261 330 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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