Electronic System Quality Assurance (ESQA) - Contract - Netherlands

Reference: RS031220AR

Expiry Date: 21-12-2021

Category Sales & Marketing

Salary: Competitive

Job Type: Contractor

Location:
Den Haag
Netherlands

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Job Description

Electronic System Quality Assurance (ESQA) - Contract - Netherlands

ADV is working closely with a Global Biopharmaceutical to supply an Electronic System Quality Assurance consultant on a 1yr renewable contract.

Primary Responsibilities:

  • 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.

Essential Job Responsibilities:

  • Integral QA representative in numerous IT project teams.  Participates in working teams to provide direction regarding quality, validation and compliance.
  • Performs and coordinates the review and approval of validation deliverables including, but not limited to, computer system requirements, validation plans, test protocols, executed testing documentation, and validation reports.
  • Work with IT staff to resolve issues identified during document reviews. 
  • Assures compliance with corporate policies, SOPs, and regulatory agency standards (US, EU, and Japan, as needed).  Identifies compliance issues and works with CSV QA staff to identify and implement corrective action as required.
  • Communicates compliance issues to ESQA management.
  • Schedules and performs assigned software vendor audits of newly identified or current, regulated and business critical software vendors.  Plan, conduct, and report results of assigned audits.
  • Assist with good manufacturing practice (GMP), good clinical practice (GCP), or good laboratory practice (GLP) audits of software vendors, software related service providers, Clinical Research Organizations, related investigational research centers, and laboratories, and as needed.  Assess the adequacy and compliance of computer validation procedures and documentation at these facilities/sites.
  • Effectively and accurately document audit findings in audit reports and obtain responses in a timely fashion.
  • Assist in the evaluation of audit responses for compliance with applicable guidelines, regulations, and company policies.  Obtain remediation when responses are unacceptable.

Required Qualifications

  • 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 Directive 1999/93/EC, and Japan PFSB Notification No. 0401022.  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.
  • Ability to work 40 hours per week plus some overtime (approximately 8-12 hours overtime per week).
  • Ability to perform approximately 5-10% travel as needed for vendor audits.  Travel will be primarily in the domestic region of resource’s primary office location (e.g. Europe, North America, or Japan).  Occasional international travel is possible. 

If this sounds like you please do get in contact with me ASAP to discuss.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Roland Schnapka on +31 (0)71 203 2098 in full confidence to receive more details on this role or to hear about other available opportunities.

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