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Manufacturing System Expert

Manufacturing System Expert

NOVARTIS

5 - 10 years

8 - 12 Lacs

hyderabad

Posted:2 months ago| Platform:

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Skills Required

automation change management sap mis process improvement pharma risk assessment hse troubleshooting technical support

Work Mode

Work from Office

Job Type

Full Time

Job Description

Define User requirement specifications (Voice of customer)

Design and create electronic batch files (EBR) with respect for quality, costs and deadlines

MBR / BOM/ Recipe creation in production IT systems

Participate in the qualification and risk assessment processes

Propose and technically validate the choice of solutions proposed by the IT teams and Automation in collaboration with the Quality team

Participate to the deployment of MES across the manufacturing units, runs performance qualification and validation batches (commissioning of the line) with the manufacturing units

Responsible for the manufacturing documentation update following the implementation of electronic batch files Provide training for MES users in partnership with the training team

Ensure follow-up and processing of deviations and Change Control in compliance with deadlines and applicable regulations Real time shop floor troubleshooting with the implementation of appropriate immediate corrective actions

Ensure the transfer of information to production teams following issues or modifications having a technical, quality or HSE impact Responsible for MES / MIS technical knowledge transfer to the shop floor Ensure the preparation of audits and inspections for related topics

Collaborate with process experts in the context of deviations related to MES / MIS and continuous process improvement

Participate to change management in close collaboration with change champion and P&O partner Ensure the application of local rules, procedures and policies

Essential Requirement:

Minimum 5 year experience in GMP manufacturing process support role Proven experience in MES expert role

University degree in Science is required, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent job experience

*Competencies Good scientific and technical (automation) understanding Deep process understanding

*Quality and compliance skills

*Team player with strong team spirit

Change management, adaptability, ability to work under pressure

Mastering of automation and computer skills

*Good understanding of regulatory requirements across multiple health authorities

*Mastering of manufacturing execution systems (MES, SAP, or other as applicable)

Good office software applications

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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Manufacturing System Expert