QA Operational Readiness Officer

Ready to engineer precision in the world of biotech? Join our client’s cutting-edge team and play a vital role in developing the instrumentation that powers tomorrow’s breakthroughs.

For the start-up of a new production facility, R&D Partners is recruiting 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.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

Change Control Coordination

• Lead change control activities as the designated Change Control Coordinator for the Plant 3 construction project
• 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)
• Ensure proper documentation, risk assessment, and approval workflows for facility modifications
• Review engineering drawings, specifications and technical documentation
• Facilitate change control meetings and maintain comprehensive change documentation
• Track implementation status of changes
• Coordinate cross-functional impact assessments
• Interface with external contractor, project team and routine organisation with respect to change controls

Daily Quality Operations

• Provide real-time quality support to project teams and contractors
• Maintain and update quality management system documentation
• 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

Key Skills and Requirements:

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

For more information, please contact Grant Van Schalkwyk.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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