Change Control Coordinator / Quality Operational Readiness Officer

Our client, a pharmaceutical organization, is establishing a new production facility and is seeking a specialist to provide technical quality oversight. This role ensures a seamless transition from construction phases to operational status while maintaining full compliance during the transformation process.

• Lead change control activities for the facility construction project as the designated coordinator.
• Review, assess, and coordinate change control requests impacting quality, facilities, utilities, and production systems.
• Ensure proper documentation, risk assessment, and approval workflows for facility modifications and expansions.
• Review engineering drawings, specifications, and technical documentation such as Master Batch Records and P&IDs.
• Provide real-time quality support to project teams and contractors while maintaining quality management system documentation.
• Support quality readiness plans and follow up on facility qualification protocols including DQ, IQ, OQ, and PQ.
• Conduct comprehensive quality risk assessments for new processes and procedures to identify potential quality impacts.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• You have 3+ years of relevant experience in the pharmaceutical or biotech industry.
• You bring expertise in change control management and coordination within a GMP environment.
• You possess a technical understanding of facility systems including HVAC, water systems, compressed air, and steam.
• You have knowledge of process validation and facility qualification principles including DQ, IQ, OQ, and PQ.
• You're proactive with strong analytical abilities and effective stakeholder management skills.

Nice to Haves

• Experience working with external contractors and vendors on large-scale projects.
• Familiarity with architectural layouts and preventive maintenance programs.

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