Posted:15 hours ago| Platform: Shine logo

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On-site

Job Type

Full Time

Job Description

As a Process Incharge for Injectable manufacturing projects, your role will involve reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ, and drawings for approval. You will verify process equipment instruments according to PI&D and electrical drawings for commissioning. Additionally, you will conduct FAT for process equipment when necessary and provide support for installation and commissioning activities. Key Responsibilities: - Verify process equipment instruments based on PI&D and electrical drawings - Conduct FAT for process equipment when required - Provide support for installation & commissioning activities - Assist in qualification activities for equipment (IQ, OQ & PQ) - Identify all process and utilities equipment field instruments, and prepare a calibration schedule - Manage the instrumentation team for calibration activities - Approve calibration vendors for third-party calibrations - Review and approve calibration certificates as needed - Coordinate with vendors for spares indents, QMS elements like change control, deviations, etc. - Attend to equipment maintenance tasks such as preventive maintenance and breakdowns - Prepare SOPs and obtain necessary approvals Qualifications Required: - 12-15+ years of experience in formulation manufacturing projects - Minimum 5-6 years of experience in formulation manufacturing projects - Strong knowledge of equipment design qualification processes - Experience in managing calibration activities and vendor relationships - Familiarity with QMS elements like change control and deviations - Ability to prepare SOPs and ensure compliance with approvals If you are interested in this role, please share your CV at nitin.shringi@knovea.com.,

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