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:
o Quality systems
o Production areas
o Utilities and facility systems
o 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:
o Master Batch Records
o Preventive Maintenance Programs
o P&IDs
o Architectural layouts
o 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:
o Design Qualification (DQ)
o Installation Qualification (IQ)
o Operational Qualification (OQ)
o 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:
o Engineering (Chemical, Mechanical, Civil, or related discipline)
o Life Sciences
o 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:
o HVAC
o Water systems
o Compressed air
o 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.