Operational Readiness Specialist Job Description
The Operational Readiness (OR) team is responsible for achieving GMP-ready status for pharmaceutical facilities. This involves ensuring regulatory compliance from start-up to product launch, aligning with client needs to deliver compliant products efficiently.
This role supports the development, execution, and oversight of OR strategy and roadmap for production start-up. Working as part of our CQV group, this role ensures a smooth transition from project commissioning to GMP-ready status to production phase, covering various critical areas including GMP readiness assessments, SOP development and training, production start-up, regulatory compliance, digital implementation and operations support.
Main Responsibilities:
* Develop an OR strategy and implementation plans to ensure seamless production start-up.
* Establish governance structures to track OR project milestones and support clients in achieving GMP readiness.
* Prepare for regulatory audits by establishing robust Quality Management Systems (QMS) to ensure all documentation is audit-ready.
* Drive operational efficiencies by utilizing digital technologies and applications.
* Lead the development of SOPs, Work Instructions, checklists, and digital learning tools to ensure personnel are adequately trained and qualified for GMP operations.
* Promote continuous improvement and lean principles to enhance operational processes and ensure OR readiness.
* Offer investigation support, such as Root Cause Analysis (RCA), for efficient troubleshooting and compliance.
* Support Industry 4.0 initiatives, including dashboard builds, data visualization, PAS/BAS alarm management strategies, and integration of digital training solutions.