01 ago - Italia
Healthcare Businesswomen’s Association
Salary Range: €33,500.00 - €62,100.00
Job Description Summary
The Pilot Plant Manufacturing & Technology Transfer Expert is responsible for technology transfer activities and front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards and to allow continuously improving in quality, productivity efficiency.
Key Responsibilities
- Provide front line expert support for all process-specific issues to production.
- Coordinate and ensure the completion of all production operations on time, in accordance with the documentation and in compliance with GMP, SSE and 5S rules.
- Ensure real time shop floor support as an expert on technical problems and ensuring that appropriate immediate corrective/remediation actions are implemented by troubleshooting and structured problem solving methodology.
- Perform real time batches follow-up and batch records technical review.
- Ensure that production documents under responsibility are systematically up to date and that the production documents necessary for the validation / revalidation of processes are available.
- Support the development of technical and scientific knowledge of shop floor technicians.
- Support production team (technician, supervisor etc) in their day to day activities.
- Collaborate to ensure the correct compilation and maintenance of product and process data records on information systems (SAP/3AGEST2, etc.).
- Lead thorough Root Cause Investigation process using investigation tools and methodology.
- Ensure timely treatment of deviations, complaints, OOE, OOS, and the implementation of effective CAPAs within agreed timelines where involved.
Minimum Requirements
- Minimum 2 year experience in GMP manufacturing support / technical role.
- Minimum 8 year experience in the field of expertise for lower education levels.
- Good scientific and technical un
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