Specialist QA

Orion Group; Breda; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Orion Group Life Sciences in Breda is seeking a Specialist QA for a multinational client on an initial 12-month contract. The role is hybrid, requiring onsite presence three days per week to support validation, QA systems, and compliance activities.

You will review validation documentation, provide QA guidance to operations, and participate in QRM, change control, and risk assessments to ensure GMP compliance across equipment, automation, and IS.

Qualifications

• Master degree required in Engineering, Pharmaceutical sciences, Process Technology or equivalent.
• 5-8 years of GMP experience preferred.
• Experience with Equipment and Automation Validation.
• 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.

Responsibilities

• Perform QA support and oversight for validation of equipment, automation and information systems.
• Review and approve equipment and automation validation documentation.
• Provide guidance to operations staff on quality policies, standards and procedures.
• Provide quality engineering support for testing strategies and quality investigations.
• Lead strategy discussions and approve validation documentation.
• Support maintenance, engineering changes and change controls.
• Manage device responsibilities and ensure GMP alignment.
• Represent QA in QRM activities and ensure policy alignment.
• Perform final review of technical change controls and QA assessments.

Skills

GMP experience

Equipment validation

Automation validation

Quality Risk Management

Change Control

Annex 11/Part 11 compliance

FMEA

Statistical tools

Attention to detail

Communication skills

Education

Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent

Job description

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.

People

People are our business worldwide.

Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.