Lead - Store & Warehousing

List Of Responsibilities

• R&D Baroda Stores – Overall upkeep & management
• Monitor Bills processing – in time GRN processing after users' acceptance / bill submission to SSC.
• Monitor material inward - receipt, delivery – Normal / Temperature controlled condition / Imported material.
• Monitor material outward - International & Domestic samples despatch under normal / temperature-controlled condition as per approved ARC / Rates through approved Couriers after proper evaluation of rates & Service
• take care of Export documentation in co-ordination with Courier, Users.
• Monitor Inventory management of stores-controlled lab chemicals / Commercial Solvents / Gen. Lab consumables / Housekeeping / Stationery items.
• Monitor manpower utilization - OT Control
• Monitor Stores upkeep.
• Monitor mailing activities - Inward / outward
• Monitor FRD WH area– API / Excipient stock management through Bin Card / WH upkeep.
• Communication to Users / HODs about procedural changes / Regulatory Updates / providing Consumption data of Stores-controlled lab-chemicals, solvents, etc.
• R & D Stores - documenting as per GST Rules
• Ensure R & D material movement document process as per GST Rules – STO generation / Invoicing through SAP system / E-way bill generation / Proper transaction closure by accounting document / cancellation of open STOs / non-dispatch invoices / return of rejected material by getting Credit notes from Vendors
• Monitor Asset movement with proper documentation – DRT approval / invoicing with proper material codes / follow insurance process.
• Monitor scrap sale transactions as per defined process with proper documentation – Invoicing under proper scrap codes as per ARC
• Monitor Returnable Material movement – process through Electronic Gate Pass System – Overall control – ensure timely closure.
• Monitor submitting of GST related reports on monthly basis to IDT Team in time.
• Regulatory compliance
• Regulatory compliances under Prohi. & Excise related licenses-DD1 / DD3 / RS2 / MA1 / AC2 as per respy. License requirement - Monitoring receipt / Storage / Issuance / stock keeping as per limit / documentation / stock register maintenance / License Renewal / Product addition under DD1 / DD3 / Record keeping as per License requirement.
• Getting APP from IC, Gandhinagar for additional Alcohol requirement & get it approved under RS-2 License for regular usage.
• NDPS products handling at NDPS CWH as per NDPS SOP - monitoring receipt / issue transactions with proper documents, NDPS category wise Stock maintenance in Bin Card, Register & excel sheet properly, monthly / quarterly / annual Return filing correctly in time, Destruction of NDPS drug products as per NDPS SOP.
• Regulatory compliance under PESO License for Solvents handling – stock management within limit, License renewal.
• Attending Regulatory Officials visits & taking appropriate action in co-ordination with Site responsible person, updating to HOD / Site Head.
• Monitoring & controlling Medicinal Product Stores Activities
• Ensure implementation of related SOPs & compliance
• SOP Compliance - LMS / PMS / EDMS / TRACKWISE Systems
• Review receipt of RLD / Test Samples, issuance, dispatch to CROs, Destruction, cleaning records.
• Review change control, discrepancy note, deviation through Trackwise system.
• Review training for adequacy & compliance in dept. thr. LMS.
• Ensure to get self inspection audit complete smoothly, review observations & provide response.
• Act as System Owner and ensure laboratory computerized systems are validated for its intended use through its lifecycle.
• Ensure the laboratory computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle.
• Facilitate the user acceptant testing for laboratory computerized systems during validation.
• Review and approve Validation and life cycle documentations of computerized systems as per quality procedures.
• Provide support / response to internal / external audit observations for laboratory computerized systems and ensure its compliance.
• Ensure resolution of identified risks related to computerized systems in a timely manner.
• Support the assessment and remediation of identified activities as part of various Corporate initiatives.
• Ensure GxP computerized systems are compliant to 21 CFR part 11 and EU Annex 11 readiness and adequate security and controls are available to ensure data security.

Skills Required

trackwise , Sap, Lms, Edms, Pms