Jay Valand Email & Phone Number

Kheda, Gj, In

Gujarat, India

1. Responsible to perform line clearance and in process checks at various stages of manufacturing and packing.2. To ensure CGMP compliance in oncology block.3. To perform sampling of intermediates finished products, Retain samples, pre-shipment and other samples at various stages of manufacturing and packing4. To ensure online documentation in BPCR and Log books during manufacturing and packing of finished products5. To verify Raw/ packing material requisition slips provided by planning department for accuracy and correctness.6. To perform AQL, of finished products as per SOP.7. To review executed BPCR's prior to batch releases.8. To perform Usage decision and othre relevant transactions in SAP.9. To initiate and approve usage decision of lots in LIMS.10. To Impart training within department and to cross functional department.11 To prepare and revise departmental SOP's based on requirement.

• Compliance of Current GoodManufacturing Practices and to follow Good Document Practices with Data Integrity compliance.• Responsible for stage wise line clearance activity before commencing the operations like dispensing, manufacturing, filling, sterilization, labelling and packing operations.• Collection of control sample, stability sample, validation sample and other (as per applicable) and maintain their records• To verify the online documentation (i.e, Batch Records, Logbooks, etc.)• To carry out reconciliation and physical verification of the returned goods.• To verify the Withdrawal of FinishedProduct & Retain Samples.• To check the cleaning of Area and inspection of record• To verify the Sampling (ie. Bulk, Zero, Finished Product, Validation and Stability)• Cleaning Validation - To carryout sampling in cleaning validation as per protocol• Process Validation - To carryout sampling in process validation as per protocol