Sr. DPEx Functional Analyst – Manufacturing Systems Full-time Job1 month ago - Pharma - Hyderabad - 36 views
- Good understanding of Biopharma manufacturing processes
- Responsible for the entire MES system through its implementation lifecycle; liaise between internal teams and external project teams and ensure task completion
- Responsible for preparation and execution of MES administration SOPs and system roles
- Assist with the design and preparation of Master Batch Records on PAS|X application
- Strong knowledge on OSI PI Data Archive, PI AF, PI EF, PI Interface, PI Vision dashboards
- Hands-on experience on L2 Equipment integration with OSI-PI (preferably Bio-reactors and other Biopharma process & analytical equipment)
- Knowledge on Data validation, PI point configuration using pi builder and through SMT; work on the OSI-Soft PI system Installation/System upgrade and Configurations
- Understand SAP system and interface scenarios between SAP and MES systems
- Setup a fully functional service desk, responsible and accountable for MES support for execution excellence
- Interact with the business users to gather & understand the business needs; Analyse process documents, workflows, conduct workshops & surveys in order to document the project scope and business requirements
- Work with architects and business partners to identify technical solutions for business process improvements; ability to prepare design document and functional requirement specification
- Coordinate with vendor support team for issue resolution and implementing corrections/ enhancements and version upgrade of Application in accordance with qualification standards and SOPs
- Understanding of 21CFR Part11 requirements for computerized systems and Computer system validation concepts
Hands on experience in Biopharma industry in Digitization, Automation & Engineering systems and Process Excellence functions
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Over the years, the company has significantly grown its portfolio of products across mass and specialty therapies. Today, our portfolio has over 200 products covering the whole spectrum of disease areas spanning gastroenterology, oncology, pain management, cardiovascular, dermatology, urology, nephrology, rheumatology and diabetes. Seven of our brands are listed in “Top-300 of the Indian Pharma Market” and many others hold leadership positions in their respective categories.