Change Control Coordinator

For the start-up of a new production facility we are looking for a Change control coordinator/Quality operational readiness officer. This critical role serves as the Change Control Coordinator while providing technical quality oversight for facility construction, modifications and utility upgrades. The position ensures seamless transition from construction phases to operational status while maintaining full GMP compliance throughout the transformation process.

Change Control Coordination

• Lead change control activities as the designated Change Control Coordinator for the Plant
• Review, assess, and coordinate all change control requests impacting quality, facilities, utilities, and production systems
  • Production area modifications and expansions
  • Utility system upgrades (HVAC, compressed air, steam, water systems)

Daily Quality Operations

• Provide real-time quality support to project teams and contractors
• Maintain and update quality management system documentation
• Review project documentation, such as Master batch records, preventive maintenance programs, P&IDs, architectural lay-outs, ...
• Escalate critical quality issues to management
• Conduct routine GEMBA walks in active construction/reconstruction areas

Operational Readiness & Compliance

• Ensure compliance with local and international GMP requirements
• Support quality readiness plans for the introduction of a new production facility
• Follow-up on quality aspects of facility qualification including DQ, IQ, OQ, and PQ protocols and coordinate with engineering teams on quality-critical facility systems (HVAC, water systems, utilities)
• Support facility design qualification and compliance with regulatory requirements

Risk Assessment & Mitigation

• Conduct comprehensive quality risk assessments for new processes and procedures
• Identify potential quality impacts from construction activities on ongoing operations and develop mitigation strategies
• Monitor risk indicators and implement preventive measures
• Assess impact of facility changes on existing validated systems

Education & Experience

• Bachelor’s degree in Engineering (Chemical, Mechanical, Civil), Life Sciences or related technical field
• 3+ years of experience in pharmaceutical/biotech industry

Core Competencies

• Proven experience in change control management and coordination
• Strong knowledge of GMP regulations and pharmaceutical quality systems
• Understanding of facility systems including HVAC, water systems, compressed air, steam, and utilities
• Understanding of process validation and facility validation/qualification principles
• Strong analytical and problem-solving abilities with technical aptitude
• Effective communication and stakeholder management skills
• Attention to detail with strategic thinking capability
• Ability to work with cross-functional teams, contractors, and external vendors

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