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Technical Process Excellence Lead – OSD Manufacturing – Gi Life Sciences | JobRevolt

Über den Job

We are recruiting a Technical Process Excellence Lead – OSD Manufacturing for a world-renowned pharmaceutical company. 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.

Aufgaben

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

Profil

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

Rahmenbedingungen

Start date: ASAP
Duration: 6 months

Technical Process Excellence Lead – OSD Manufacturing

Über den Job

Über den Job

Aufgaben

Profil

Rahmenbedingungen

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