QA Electronic Systems Specialist

Opdrachtgever

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

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.

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.