QA Electronic Systems Specialist

  • Randstad
  • 0.00 - 0.00
  • hours

Client

Our client is active in the food, life sciences, infrastructure, oil and gas and (petro) chemical markets by delivering:

  • Support through consulting & engineering;
  • delivering turnkey automated solutions;
  • maintenance and support.

Client

Our client is active in the food, life sciences, infrastructure, oil and gas and (petro) chemical markets by delivering:

  • Support through consulting & engineering;
  • delivering turnkey automated solutions;
  • maintenance and support.

Requirements

  • Minimum B.A. / B.S. with at least 3-5 years in Quality Assurance position (or similar) within pharmaceutical environment or healthcare field. Experience in IT Compliance roles will be considered.
  • Must have Computer System Development Life Cycle and Validation experience. Computer System Validation Quality Assurance / Software Quality Assurance experience desirable.
  • Must understand global regulatory requirements for electronic records and electronic signatures including but not limited to: CFR 21 Part 11, EU Annex 11, EU.
  • Must understand associated regulatory guidance documents.
  • Must understand computer systems validation process, and process controls in the areas of GAMP 4 / GAMP 5, ISO 9000, ITIL, IEEE, and ASQ standards.
  • GxP computerized auditing experience required; Pharma, GMP, GCP, and GLP auditing experience desirable. Ability to represent the company to external stakeholders during vendor audits required.
  • Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to develop and maintain effective relationships across company groups and external stakeholders.
  • Must be capable of managing self and project teams across multiple assigned projects.

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

  • Responsible for assisting Electronic Systems Quality Assurance in overseeing the Computerized Systems Validation Program
  • Responsible for representing Electronic Systems Quality Assurance on Information Systems Compliance program related continuous process improvement initiatives.
  • Responsible for reviewing and approving Computer System Validation documents to ensure compliance with written policies and procedures.
  • Provides guidance to drive consistent GxP and Electronic Records / Electronic Signatures regulations compliance and validation approaches across projects to ensure compliance with regulations, and company policies and procedures.
  • Schedules and performs assigned computerized systems audits related to the purchase or use of software.
  • Supports new technology initiatives as the company continually invests in new processes and R&D computerized systems.

TAGCLOUD

Peter Debrichy

Interested

Send your resume to peter@tailorminds.com referring to job id (875)

More information?

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

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