QA Operational Pharma [F/M/X] - #45410

Job Description

Position Overview

We are seeking a motivated and experienced Change Control Coordinator / Quality Operational Readiness Officer to support the start-up of a new pharmaceutical production facility. This role is critical in ensuring quality oversight during facility construction, modifications, utility upgrades, and operational readiness activities while maintaining full GMP compliance throughout the project lifecycle.

The successful candidate will act as the designated Change Control Coordinator and work closely with engineering teams, contractors, quality stakeholders, and operations to ensure a smooth transition from project execution to commercial operations.

Experience Level

• 4–6 years of relevant experience preferred
  
  

Key Responsibilities

Change Control Coordination

• Lead and coordinate change control activities related to facility construction and operational readiness projects
• Review, assess, and manage change requests impacting:
• Quality systems
• Production areas
• Utilities and facility systems
• Manufacturing processes
• Support modifications and expansions of production areas and infrastructure
• Coordinate utility upgrades including HVAC, compressed air, steam, and water systems
• Ensure appropriate documentation, risk assessments, approvals, and implementation tracking are completed
• Review engineering drawings, specifications, and technical documentation
• Facilitate change control meetings and maintain accurate records
• Coordinate cross-functional impact assessments
• Interface with project teams, contractors, engineering, and operational stakeholders
  

Quality Operations Support

• Provide day-to-day quality support to project teams and contractors
• Maintain and update Quality Management System (QMS) documentation
• Review project-related documentation including:
• Master Batch Records
• Preventive Maintenance Programs
• P&IDs
• Architectural layouts
• Technical and validation documents
• Escalate critical quality issues when required
• Perform routine GEMBA walks in active construction and reconstruction areas
  

Operational Readiness & GMP Compliance

• Ensure compliance with local and international GMP requirements
• Support quality readiness activities for the launch of a new production facility
• Participate in facility qualification activities including:
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Coordinate with engineering teams on quality-critical systems and utilities
• Support facility design reviews and regulatory compliance activities
  

Risk Assessment & Mitigation

• Conduct quality risk assessments for new systems, processes, and procedures
• Identify quality risks associated with construction and operational changes
• Develop and implement mitigation strategies
• Monitor risk indicators and preventive actions
• Assess the impact of facility changes on validated systems and existing processes
  
  

Required Qualifications

Education

• Bachelor’s degree in:
• Engineering (Chemical, Mechanical, Civil, or related discipline)
• Life Sciences
• Or another relevant technical field
  

Experience

• Minimum 3 years of experience in the pharmaceutical or biotech industry
• Experience in GMP-regulated environments is essential
• Previous experience with change control coordination is strongly preferred
  
  

Required Skills & Competencies

• Strong knowledge of GMP regulations and pharmaceutical quality systems
• Proven experience in change control management and coordination
• Understanding of facility and utility systems:
• HVAC
• Water systems
• Compressed air
• Steam systems
• Knowledge of validation and qualification principles
• Strong analytical and problem-solving capabilities
• Excellent communication and stakeholder management skills
• Ability to work effectively with cross-functional teams, contractors, and external vendors
• Detail-oriented with strong organizational and strategic thinking abilities
  

Why joining us?

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.

Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.

International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, We Strive To Provide Our Candidates With The Best Possible Recruitment Experience. We Like To Get To Know Our Candidates, Challenge Them, And Be Able To Give Them Proper Feedback As Quickly As Possible. Here's What Our Recruitment Process Looks Like

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!