Dr. Reddys Laboratories is an emerging global pharmaceutical company with proven research capabilities. The company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.
Post : Sr. DPEx Functional Analyst – Manufacturing Systems
Job Description
• 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
Candidate Profile
Hands on experience in Biopharma industry in Digitization, Automation & Engineering systems and Process Excellence functions
Additional Information
Qualification : Any graduate/diploma
Location : Bachupally, Hyderabad, Telangana, India
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th November , 2021
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