01 Oct
|
Zydus Group
|
India
Job Description
We're Hiring | Deputy Manager/Associate Manager /Manager- MES (Functional & Technical)
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Location: SEZ-II, Ahmedabad
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Department: Digitalization
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Role -MES (Functional & Technical)
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Designation: Deputy Manager/Associate Manager /Manager
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Zydus is seeking an experienced MES (Manufacturing Execution System) skilled to drive our digital manufacturing transformation journey through MES and eBMR implementation. The role will encompass both Functional MES and Technical MES/IT responsibilities, enabling seamless integration between manufacturing operations and digital technologies.
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Role 1: MES Functional Lead
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Key Responsibilities :
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- Lead MES/eBMR implementation projects across pharmaceutical manufacturing sites.
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- Conduct requirement gathering workshops with Manufacturing, Quality, Engineering, and Business stakeholders.
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- Prepare and review URS, Functional Specifications, VMP, IQ/OQ/PQ, and validation documentation.
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- Configure MES workflows aligned with manufacturing and quality processes.
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- Drive user adoption through training, workshops, and change management initiatives.
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- Ensure compliance with GxP, Data Integrity, 21 CFR Part 11, ISA-95, and GAMP standards.
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- Coordinate with vendors and cross-functional teams to deliver successful MES deployments.
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Required Expertise
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- Hands-on experience with Koerber PAS-X MES and eBMR implementation.
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- Strong understanding of pharmaceutical manufacturing processes.
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- Experience in Computer System Validation (CSV) and qualification activities.
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- Knowledge of GxP regulations, Data Integrity, ISA-95, and GAMP guidelines.
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Role 2: MES Technical / IT Lead
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Key Responsibilities :
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- Design, implement, and support MES architecture and infrastructure.
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- Manage MES master data, electronic logbooks, workflows, and system configurations.
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- Lead MES integrations with SAP, LIMS, SCADA, DCS, PLCs, Historian, and other en
📌 Digitalization MES (India)
🏢 Zydus Group
📍 India