OverviewPM Group's Operational Readiness (OR) team specialises in achieving GMP-ready status for pharmaceutical facilities.
With a proven approach to ensuring regulatory compliance from start up to product to market, the OR team can provide oversight from commissioning through to GMP readiness, aligning with client needs to deliver compliant products efficiently.
The Operational Readiness Specialist will support 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.
The ideal candidate will have experience in delivering OR within a GMP environment, strong project management skills, and the ability to communicate and coordinate cross-functional teams effectively.
ResponsibilitiesDevelop OR strategy and implementation plans.Develop governance structures to track OR project milestones and support the client's journey to GMP readiness.Prepare for regulatory audits by establishing robust Quality Management Systems (QMS) to ensure that the full documentation suite (SOPs, WIs, training records, etc.)
are audit ready.Drive operational efficiencies utilizing digital technologies and applications.Lead the development of SOPs, Work Instructions, checklists, and digital learning tools, ensuring all personnel are adequately trained and qualified for GMP operations.
Provide technical writing and redline support for SOP development.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.QualificationsBachelor's degree in engineering, Life Sciences, or a related field.Minimum of 5+ years of experience in operational readiness, regulatory compliance, or project management within a GMP environment.Strong knowledge of cGMP standards and regulatory requirements for pharmaceutical manufacturing.Proficiency in project management and digital tools (e.g.
SAP, MES, dashboard platforms).Exceptional communication and cross-functional collaboration skills.Experience with Health, Safety, and Environment (SHE) standards in regulated environments is a plus.
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