Roles and Responsibilities 1. Review of Technology data package and preparation of Gap analysis document. 2. Preparation of technology transfer protocol and report. 3. Co-ordination with FD for smooth Tech Transfer. 4. Monitoring of validation batches at production site. 5. Perform Feasibility trials, Product evaluation trials to understand critical process parameter for smooth transfer and process understanding. 6. Review of MPCR and protocol. 7. Planning for Execution of Process design, Process qualification batch. 8. Coordination with Production, Quality assurance, Quality control, Engineering, Regulatory Affairs, SCM and warehouse for the TT activities. 9. Should be part of handling deviation, change control and failure investigations. 10. Process manufacturing parameters for Qualification batches Vs Commercial batches. 11. Preparation and reviewing of intended batch documents for regulatory submission. 12. Trouble shooting of existing products and process improvement to increase output or to reduce processing time or to improve the quality of products.
Responsibilities: Drafting of IT SOPs and Protocols. Performing regular backup and periodic restoration of data. Creation of User ID and projects in analytical softwares. Handling of applications like abSolutions, Empower Chromeleon and other standalone software of quality department and FBD, Coating machines, SCADA/HMI. SAP B1 and SAPA HANA IT Admin support experience. Handling of backup applications and performing Bare Metal (OS Image) backup and restoration as per policy Experience on applications like QMS, DMS and LMS. Awareness of IT GxP, Data Integrity (ALCOA++), GAMP 5, 21 CFR Part 11, and Annexure 11. Supported to vendor to implement to LIMS in Analytical Lab. Ensure GxP Computerized Systems are validated as per GAMP -5, 21 CFR Part 11, EU annex 11 and assessments for Quality control & production systems Handling and resolving a day-to-day issue and providing a technical support to users. Troubleshooting, MS Windows (Server 2008/2012 R2, 2016, 2019 windows XP, 7, 8, 10, 11) desktop and server related compliance issues. Install/Configure and manage server operating system. Handling of AD server, File server Microsoft operating system and Microsoft office suite. Installing and configuring software, windows patch updates, network printers configuration. Basic Network Administration of Firewall, Routers, VPN Management and Access controls. Basic Google workplace and O365 administration. Creation and managing of users and groups of mail, outlook configuration. Manufacturing equipments like Blister packing machine, Tracking and serialization softwares. (BPO system, Zenon) Preferred candidate profile Any Graduation with good Communication Skill. 2- 4 Years of Experience in relevant Industries. Timely support in all the shifts.
Key Responsibilities: 1. Strategic Procurement Planning: Develop and execute procurement strategies aligned with production schedules and business goals. Plan material requirements proactively in coordination with Production Planning and Control (PPC) to ensure zero stock-outs. 2. Vendor Development & Management: Identify, qualify, and onboard reliable vendors for APIs, excipients, and packing materials. Build long-term supplier relationships and negotiate competitive terms and conditions. Monitor vendor performance on delivery, quality, and compliance. 3. Cost Optimization & Budget Control: Drive cost-saving initiatives while maintaining quality and regulatory compliance. Conduct market analysis and benchmarking to support strategic sourcing. Track procurement budgets and ensure cost-effective purchasing decisions. 4. Regulatory & Quality Compliance: Ensure all procured materials meet quality, cGMP, and regulatory requirements. Coordinate with QA/QC and Regulatory Affairs for documentation, approvals, and vendor audits. Maintain compliance for all procurement-related documentation and systems. 5. Operational Coordination: Collaborate with cross-functional teams including Production, QA/QC, Stores, and Finance. Manage timely issuance and follow-up of Purchase Orders in SAP/ERP systems. Handle material deviations, rejections, and supplier non-conformances efficiently. 6. MIS & Reporting: Prepare and maintain procurement reports, supplier evaluation metrics, and material status reports. Monitor inventory levels, lead times, and stock ageing for continuous improvement. Preferred candidate profile Education: B.Pharm / B.Sc / M.Sc / MBA (Supply Chain / Operations preferred) Experience: 8 -12 years in procurement of APIs, excipients, and packing materials in a regulated formulation plant Technical Skills: Strong negotiation, vendor management, and strategic sourcing expertise Proficiency in ERP/SAP systems Knowledge of regulatory and quality requirements (USFDA, WHO-GMP, etc.) Excellent analytical, communication, and cross-functional coordination skills