QA Validation Officer

  • Groningen
  • 2500.00 - 3000.00
  • 32-40 hours
  • Bachelor degree

Client

Our client is a consultancy in the food and pharmaceutical industry.

Client

Our client is a consultancy in the food and pharmaceutical industry. They participate in very attractive projects for experienced engineers in the pharmaceutical industry. They offer challenging, varied projects with ample opportunities for personal contributions and development.

Requirements

  • Bachelor’s Degree in Science, Engineering, IT or related fields.
  • 2 to 3 years proven experience in a Validation role and/or Technical role in combination with relevant quality experience in a Biotech/ Biopharma/ cGMP environment.
  • Must have experience in a regulated industry, with related technical knowledge of data integrity related to quality control data from laboratory instrumentation and operations equipment and associated computer systems.
  • Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (GDocP).
  • Solid knowledge of 21CFRPart 11, 210,211,Annex 11, 15, MHRA ‘GXP’ Data Integrity Guidance and Definitions.
  • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
  • Effective written, interpersonal, and presentation skills.
  • Ability to work on multiple projects simultaneously.

What do you get?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Duties

  • Support and provide cGMP guidance, document review and approval, deviation handling and advice regarding documentation quality practices.
  • Calibration and maintenance support in equipment and system lifecycle.
  • Quality review and approval of change controls using Trackwise.
  • Quality review and approval of validation documentation (FAT, SAT, IQ, OQ, PQ, etc.)
  • Perform annual audit trail review of GMP computerized and electronic systems within laboratory, manufacturing, and engineering departments.
  • Reviews user access list of computerized and electronic systems and meet with area managers/supervisors to align user list with existing authorized users.
  • Creates detailed work instructions for electronic data access and review process for manufacturing systems.
  • Supports the update of existing site documents as needed, to implement the electronic data review process for manufacturing systems.

TAGCLOUD

qualityassurance
#validation
#validationdocumentation
#GMP
#GDP
Peter Debrichy

Interested

Send your resume to peter@tailorminds.com referring to job id (943)

More information?

Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

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