Technical Supervision, senior Supervisor – Technology
Il y a 21 heures
Tangier-Tetouan-Al Hoceima, Maroc
SPIMACO
Temps plein
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Job Summary
Responsible for coordinating, executing and monitoring the transfer of pharmaceutical products, manufacturing processes, analytical methods and associated technical knowledge from development, external manufacturing partners or other manufacturing sites to the Tangier site. The job holder ensures that technology transfers comply with Good Manufacturing Practices (GMP), regulatory requirements, approved technical documentation, quality standards and project timelines.
Main Purpose of Job
The main purpose of this position is to supervise technical aspects of technology and industrial transfer activities, acting as a key interface between Production, Quality Assurance, Quality Control, Regulatory Affairs, Engineering, Supply Chain and external partners, to ensure the successful industrialization and sustainable commercial production of transferred products.
MAIN RESPONSIBILITIES
Strategic Responsibilities
▪ Technology Transfer Management: Plan, coordinate and monitor technology transfer activities (new products, line transfers, site transfers and process changes) in line with the plant's portfolio and production objectives.
▪ Process Optimization: Contribute to the industrialization of new products and the optimization of existing processes to improve robustness, productivity, yield and quality.
▪ Continuous Improvement: Drive continuous improvement initiatives in manufacturing processes and standardize transfer procedures, tools, templates and best practices.
▪ Compliance Assurance: Ensure adherence to GMP, regulatory commitments and industry best practices across all transfer activities.
▪ Risk Management: Apply risk-based approaches and scientific principles; identify and escalate technical, quality and project risks.
▪ Collaboration: Collaborate with cross-functional teams and external partners to achieve transfer and production objectives.
Functional Responsibilities
A. Technology Transfer Execution
▪ Review and assess technology transfer packages received from R&D, sending sites, licensors or contract manufacturing organizations (CMOs).
▪ Coordinate the preparation and execution of transfer plans, protocols and reports, and ensure the completeness and consistency of technical documentation.
▪ Identify technical gaps, process differences and potential risks between the sending and receiving sites.
▪ Ensure that manufacturing processes are properly transferred, understood and reproducible at the receiving site.
▪ Monitor milestones, deliverables and timelines, escalating deviations from the project plan when necessary.
B. Process and Manufacturing Readiness
▪ Assess equipment, facilities, utilities, capacity and technical capabilities required for product transfer.
▪ Coordinate process familiarization, engineering and trial batches, and process qualification activities.
▪ Support the definition of manufacturing parameters, process instructions and batch manufacturing records; ensure critical process parameters (CPPs) and critical quality attributes (CQAs) are identified and controlled.
▪ Work closely with Production to resolve technical issues during process implementation.
▪ Support process validation, cleaning validation and continued process verification with the relevant departments.
▪ Ensure transferred processes are suitable for routine commercial manufacturing and meet quality and productivity objectives.
C. Analytical Methods and Quality Coordination
▪ Coordinate the transfer of analytical methods between sending and receiving Quality Control laboratories, including protocols, acceptance criteria and reports.
▪ Work with Quality Control to address analytical discrepancies, method performance issues and laboratory readiness.
▪ Coordinate with Quality Assurance to ensure GMP compliance and traceability of transfer activities.
▪ Participate in risk assessments, deviation investigations, root cause analyses and the definition of CAPAs.
▪ Ensure changes arising from technology transfer are managed through the approved change control system.
D. Regulatory and Documentation Compliance
▪ Coordinate with Regulatory Affairs to assess the impact of process, site and analytical method changes on marketing authorizations.
▪ Verify that transferred processes and documentation remain consistent with approved product dossiers.
▪ Contribute to the preparation and review of technical documentation supporting regulatory submissions and inspections.
▪ Ensure that protocols, reports, technical assessments and supporting records are complete, accurate, approved and properly archived.
▪ Support internal audits, external inspections and regulatory authority inspections related to technology transfer.
E. Project Coordination and Cross-Functional Collaboration
▪ Coordinate transfer project activities across Production, QA, QC, Regulatory Affairs, Engineering, Maintenance, Supply Chain and other functions.
▪ Organize project meetings, monitor action completion, and maintain project plans, timelines, risk registers and status reports.
▪ Communicate technical issues, risks, resource constraints and progress to the Technical Manager.
▪ Coordinate technical exchanges with external partners, licensors, CMOs and sending sites.
▪ Ensure a smooth handover of transferred products to routine manufacturing operations.
F. Team Supervision and Development
▪ Coordinate day-to-day activities of assigned technology transfer personnel: allocate tasks, monitor progress and ensure adherence to project priorities.
▪ Provide technical guidance and support to team members; identify training needs and develop technical competencies.
▪ Promote collaboration, accountability and a strong quality culture, ensuring compliance with site procedures, GMP and safety standards.
▪ Share technical knowledge and lessons learned across relevant departments.
Other Responsibilities
▪ Performs other related duties and tasks as directed.