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.
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.
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