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Chakan, India Enzene Biosciences Ltd Full timePerform validation of computer systems in compliance with industry standards.Develop and execute validation strategies, including risk assessments and validation protocols.Collaborate with cross-functional teams to ensure seamless integration and operation of validated systems.Develop and implement validation strategies for computer systems and...
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Executive/Senior Executive- IT
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chakan, India Enzene Biosciences Ltd Full timePerform validation of computer systems in compliance with industry standards.Develop and execute validation strategies, including risk assessments and validation protocols.Collaborate with cross-functional teams to ensure seamless integration and operation of validated systems.Develop and implement validation strategies for computer systems and...
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Executive/Senior Executive- IT
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Chakan, India Enzene Biosciences Ltd Full time- Perform validation of computer systems in compliance with industry standards.- Develop and execute validation strategies, including risk assessments and validation protocols.- Collaborate with cross-functional teams to ensure seamless integration and operation of validated systems.- Develop and implement validation strategies for computer systems and...
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Executive/Senior Executive- IT
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Chakan, India Enzene Biosciences Ltd Full time- Perform validation of computer systems in compliance with industry standards.- Develop and execute validation strategies, including risk assessments and validation protocols.- Collaborate with cross-functional teams to ensure seamless integration and operation of validated systems.- Develop and implement validation strategies for computer systems and...
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Executive- Packing
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Executive- Packing
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Chakan, India Enzene Biosciences Ltd Full timeSupervise overall packing and visual inspection operations in the fill-finish area.Prepare and maintain GMP documentation, including but not limited to SOPs, BPRs, protocols, reports, and equipment qualification documents.Ensure all fill-finish packing equipment are installed, qualified, and maintained in operational condition.Manage material inventory and...
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Executive- Packing
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Executive- Packing
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Chakan, India Enzene Biosciences Ltd Full time- Supervise overall packing and visual inspection operations in the fill-finish area.- Prepare and maintain GMP documentation, including but not limited to SOPs, BPRs, protocols, reports, and equipment qualification documents.- Ensure all fill-finish packing equipment are installed, qualified, and maintained in operational condition.- Manage material...
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Executive- Packing
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Chakan, India Enzene Biosciences Ltd Full time- Supervise overall packing and visual inspection operations in the fill-finish area. - Prepare and maintain GMP documentation, including but not limited to SOPs, BPRs, protocols, reports, and equipment qualification documents. - Ensure all fill-finish packing equipment are installed, qualified, and maintained in operational condition. - Manage material...
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Senior Engineer
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Chakan, Chakan MahTower, IN Mahindra And Mahindra Limited Full time ₹ 20,00,000 - ₹ 25,00,000 per yearSenior Engineer - PTD MTBD Responsibilities & Key Deliverables Responsible for DVP finalization and execution - Component level and Engine level. - Crankcase, cylinder head, FEAD, valve train, Intake & Exhaust layout etc Responsible for preparing the 3D model and 2D for the different engine components Interaction with supplier finalizing the...
Executive/Senior Executive- IT
4 weeks ago
- Perform validation of computer systems in compliance with industry standards.
- Develop and execute validation strategies, including risk assessments and validation protocols.
- Collaborate with cross-functional teams to ensure seamless integration and operation of validated systems.
- Develop and implement validation strategies for computer systems and applications.
- Ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP).
- Coordinate and execute validation testing, including IQ, OQ, and PQ.
- Provide training and support to IT and business teams on validation processes and requirements.
- Participate in internal and external audits, providing necessary documentation and support.
- Continuously improve validation processes and procedures to enhance efficiency and compliance.
- Prepare and present validation reports and findings to stakeholders and management.
- Troubleshoot and resolve validation-related issues as they arise.
- Skills in executing User Acceptance Testing (UAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Knowledge of system lifecycle management and change management processes.
- Strong knowledge of regulatory requirements and industry standards related to computer system validation.
- Experience with validation of various types of systems, including ERP, LIMS, and MES.
- Proficiency in enterprise systems, quality control (QC) systems, and manufacturing equipment validation.
- Strong analytical skills for identifying and resolving validation-related issues.
- Ability to conduct root cause analysis and implement corrective actions.
- Experience with project management methodologies (e.g., Agile, Waterfall).
