Process Expert (MS&T)

Band

Level 3

 

Job Description Summary

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals.

The Process Expert will provide 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 (e.g, HSE) and to allow continuously improving in quality, productivity efficiency.

 

Job Description

Major accountabilities:

Operational Activities:

·        Provide front line expert support for all process-specific issues to production

·        Act as Subject Matter Expert (SME) for the product and process

·        Support manufacturing to 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.

·        Perform real time batches follow-up and batch records technical review

·        Ensure that all production documents are systematically up to date and that the production documents necessary for the validation / revalidation of processes are available

·        Execute validations when/where needed

·        Manage the preparation and execution of changeover activities between campaigns by ensuring availability of equipment, consumables, raw materials, documentation and providing Change Over training to technicians

·        Transfer of information and increase awareness of production teams following problems or modifications having a technical, quality or HSE impact

·        Develop technical and scientific knowledge of shop floor technicians

·        Conduct training to ensure process knowledge for operators

·        Support the T&L organization in defining and maintaining appropriate qualification criteria for in-scope areas of expertise

·        Support the T&L organization in defining and maintaining training to support associates achieving qualifications

·        Deliver instructor-led training for areas of in-scope expertise

·        Promote Quality and HSE culture on the shop floor

Compliance Activities:

·        Ensure timely treatment of deviations, complaints, OOE, OOS, and the implementation of effective CAPs within the agreed timelines.

·        Lead thorough Root Cause Investigation process using investigation tools and methodology.

·        Support Validation Experts and Product Stewart with process deviations

·        Ensure that all process changes in assigned products are managed through appropriate change control procedure

·        Support Validation Experts and Product Stewart regarding the definition of the validation strategy

·        Prepare, support and follow-up of Health authority and internal inspections

·        Support Regulatory Compliance QA for dossier submissions, revisions...

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