As a Quality Assurance Specialist, you will provide essential QA support and oversight for the validation of equipment, automation, and information systems, alongside managing Quality Risk Management initiatives. You will be responsible for reviewing and approving validation documentation, ensuring adherence to Corporate, Site, and Regulatory requirements. Your guidance will be vital for operations staff to comply with quality policies, standards, and procedures. Additionally, you will support quality engineering efforts for testing strategies and quality investigations.

Responsibilities

• Process, Equipment, and IS Validation: Collaborate with PD, M&E, and IS to agree on strategies and provide guidance on design, characterization, and validation, ensuring GMP quality and compliance. Review and approve validation documentation.
• Maintenance & Engineering Support: Review and approve changes to equipment, including parameter changes and like-for-like assessments. Review and approve changes to M&E procedures, such as changeover processes and maintenance practices.
• Device and Combination Product: Manage ABR’s device responsibilities, ensuring alignment with GMP regulations.
• Quality Risk Management (QRM): Represent QA in QRM activities, ensuring alignment of site Quality Risk activities with corporate policy and strategy. Review quality risk assessment summary reports.
• Change Control: Conduct final reviews of technical change controls, confirming stakeholder assessments are complete and accurately represented.

Qualifications

The ideal candidate will possess a combination of education, experience, and knowledge necessary to perform the duties of this position:

• Minimum Requirements:
  • Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or equivalent.
  • 5-8 years of professional experience in a GMP environment.
  • Relevant experience in Equipment and Automation Validation.
  • Proven experience with GMP, equipment and automation/IS validation, and computer compliance (Annex 11, Part 11).
  • Proven experience with risk management tools such as FMEA.
  • Proven experience with statistical tools for sampling plans and hypothesis testing.
• Preferred Requirements:
  • Experience in the pharmaceutical industry.
  • Experience with Nonconformances, CAPAs, and Change Control.

If you are interested in this opportunity, please send your CV to Daria at d.finikova@panda-int.com or call +31202044502.