Pharma Manufacturing Process Analyst / Manufacturing Systems Specialis ProvenTech Consulting Pvt Ltd

8.0 - 13.0 years

1 - 6 Lacs

Hyderabad

Work from Office

Job Title: Pharma Manufacturing Process Analyst / Manufacturing Systems Specialist Job Summary: We are seeking a skilled Manufacturing Systems Analyst with strong domain expertise in pharma manufacturing processes and experience working with pharmaceutical manufacturing systems (MES, SCADA, DCS, Historian systems, etc.). The role involves review and analysis of manufacturing data, including audit trail reviews , alerts , and alarms monitoring , to support digital operations and ensure regulatory compliance. Key Responsibilities: Act as a functional SME for pharma manufacturing processes , providing process insights to support system operations and investigations. Review and analyze audit trail data generated from manufacturing systems to ensure data integrity and compliance with ALCOA+ principles. Perform periodic review of alerts , alarms , and exception logs as part of routine monitoring and deviation investigations. Collaborate with production, QA, and IT teams for resolution of issues related to manufacturing systems. Support the digitization and continuous improvement initiatives in manufacturing areas. Participate in system validations, including URS development, system configuration reviews, and functional testing. Prepare and maintain SOPs and system documentation related to manufacturing systems usage and monitoring. Train end-users on manufacturing systems functionalities and regulatory requirements. Required Skills and Qualifications: Strong understanding of pharma manufacturing processes (Batch Processing, Equipment Usage, Environmental Monitoring, etc.). Hands-on experience working with Pharma Manufacturing Systems (MES, DCS, SCADA, Historian platforms). Good knowledge of audit trail review and interpretation of manufacturing system logs. Understanding of alerts , alarms , and deviation data as part of electronic record review. Familiarity with data integrity guidelines (21 CFR Part 11, EU Annex 11, WHO TRS). Experience in handling system compliance documentation (SOPs, URS, validation reports). Ability to collaborate effectively with QA, Manufacturing, and IT stakeholders. Preferred Qualifications: Knowledge of GAMP 5 , CSV principles, and pharma regulatory requirements. Experience in data review from systems like Siemens Simatic, Emerson DeltaV, Rockwell Automation, PAS-X, or similar MES/DCS platforms . Exposure to Industry 4.0 and digital transformation initiatives in manufacturing.

Posted 6 days ago

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