Project lead • genf
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We are recruiting a Technical Process Excellence Lead – OSD Manufacturing for a world-renowned pharmaceutical company.
Start date : ASAP
Duration :: 6 months
Main mission:
Provides technical leadership to ensure robust, compliant and efficient manufacturing processes. Responsible for complex documentation, the life cycle of equipment and expert in processes, MES and data integrity. Contributes to operational excellence through the field, cross-functional collaboration, continuous improvement, quality event management, and change management.
Tasks :
• Provide expertise in manufacturing processes
• Review and approve the protocol for the technical batches
• Bring expertise to the ground during risk assessments.
• Write rework/reconditioning protocols
• Write and possess technical documentation
• Participation in commissioning, FAT/SAT, IOQ, PQ, and operational preparation for new equipment
• Provide expertise in the use of the SAP, MES, and human-machine interface (HMI) process automation system for equipment
• Define the system requirements and the associated quality records and support documentation (for example, change management, etc.) to support equipment improvement after a product is marketed or the manufacturing process
• Contribute to the requirement of the MES functional system and support the creation of MES/PRC/UAT recipes as an SME process unit
• Lead to the assessment of risks related to data integrity
• Prepare and assist operations teams with setting up new equipment and troubleshooting
• Management of suppliers related to manufacturing demand
• Review the equipment qualification documentation
• Act as a business manager in the periodic review and approval of the system
• Use the investment process for capital creation
• Act as the main point of contact for the manufacturing purchase order
• Write, review, and approve the LO/TO documentation (for example, ECP)
• Participate in process troubleshooting and performance improvement projects.
• Lead A3 problem-solving initiatives related to technical topics
• Own and lead local continuous improvement initiatives.
• Provides technical expertise for investigation, CAPAs, process improvement, and other areas on request
• Participate in audits and inspections
• Ensure the timely closure of quality files (for example, CAPA, action, periodic document review, etc.).
• Change control by the owner and manager, at the discretion of the production team
• This job description is not intended to be exhaustive; additional tasks and responsibilities may be assigned as needed to meet the company’s requirements.
• Profile:
• Bachelor’s degree (or equivalent) in engineering or life sciences
• Experience of 3 to 5 years in a GMP environment, ideally in technical operations
• Strong knowledge of validation and technical documentation writing
• Proficiency in French required, good level of English
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