Specialist QA

Orion Group Life Sciences are looking for a Specialist QA for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with a high possibility of extension. Hybrid role, where you are required to be onsite three days a week.

Accountabilities

• Perform QA support and oversight for validation of equipment, automation and information systems.
• Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
• Provide guidance and direction to operations staff in regard to compliance with quality policies, standards and procedures.
• Provide quality engineering support for testing strategies and quality investigations.

Main Responsibilities of the role

• Process, equipment and IS validation.
  • Agrees on strategy and provides guidance regarding design, characterization and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance.
  • Reviews and approves validation documentation.
• Maintenance & Engineering support.
  • Reviews and approves changes to equipment (e.g. parameter changes, like for like assessments, …).
  • Reviews and approves changes to M&E procedures (e.g. change over process, preventive and corrective maintenance).
• Device and combination product.
  • Manages ABR’s device responsibilities and ensures alignment with GMP regulations.
• Quality Risk Management (QRM).
  • Represents QA in QRM activities (pFMEA, QRAES, Computer system compliance).
  • Ensures alignment of site Quality Risk activities with corporate policy and strategy.
  • Reviews quality risk assessment reports.
• Change control.
  • Performs final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
  • Functions as QA SME and collects input from different QA areas to complete the QA assessment for technical changes.

Required Qualifications and skills

• Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent.
• 5-8 years of professional experience in GMP environment.
• Relevant experience in Equipment and Automation Validation.
• Experience with pharmaceutical industry.
• Experience with Nonconformances, CAPAs and Change Control.
• Proven experience with GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
• Proven experience with risk management tools such as FMEA, etc.
• Proven experience with statistical tools to support e.g. sampling plans and hypothesis testing.
• Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
• Good understanding of quality engineering tools.
• Keeps overview but also deep dives when appropriate.
• Effective communication skills at multiple levels and areas (inside and outside of Quality).
• Good attention to detail and excellent writing skills.
• Good decision making skills and ability to apply risk based approach.
• Team player, constructively working together towards solutions.

If you would like to have a confidential conversation regarding this opportunity, please reach out to Tim Browaeys, [email removed] or contact Tim on [phone removed]

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