Operational Readiness in GMP Environments
At PM Group, our Operational Readiness (OR) team is dedicated to ensuring pharmaceutical facilities achieve GMP-ready status. We adopt a proven approach to guarantee regulatory compliance from start-up to product launch. Our OR specialists provide oversight from commissioning through to GMP readiness, aligning with client needs for efficient and compliant product delivery.
The OR Specialist role involves supporting the development, execution, and oversight of OR strategies and roadmaps for production start-ups. Working within our CQV group, this position ensures a seamless transition from project commissioning to GMP-ready status to production phase. Critical areas include GMP readiness assessments, SOP development and training, production start-up, regulatory compliance, digital implementation, and operations support.
Main Responsibilities
* Developing Operational Readiness Strategies: Create and implement plans to ensure a smooth transition from project commissioning to GMP-ready status.
* Governance Structure Development: Establish frameworks to track OR project milestones and support clients' journeys to GMP readiness.
* Regulatory Compliance and QMS: Prepare for audits by establishing robust Quality Management Systems (QMS) to ensure documentation suites are audit-ready.
* Digital Implementation and Efficiency: Drive operational efficiencies using digital technologies and applications.
* SOP Development and Training: Lead the development of Standard Operating Procedures (SOPs), Work Instructions, checklists, and digital learning tools, ensuring personnel are adequately trained and qualified for GMP operations.
* Continuous Improvement and Lean Principles: Promote continuous improvement and lean principles to enhance operational processes and ensure OR readiness.
* Investigation Support: Offer investigation support, including Root Cause Analysis (RCA), for efficient troubleshooting and compliance.
* Industry 4.0 Initiatives: Support Industry 4.0 initiatives, including dashboard builds, data visualization, PAS/BAS alarm management strategies, and integration of digital training solutions.
Qualifications and Requirements
* Bachelor's degree in engineering, Life Sciences, or a related field.
* Minimum 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, such as SAP, MES, and dashboard platforms.
* Exceptional communication and cross-functional collaboration skills.
* Experience with Health, Safety, and Environment (SHE) standards in regulated environments is an asset.