Verification validation jobs in Dholka

 ...Test Procedures of Raw Materials, Finished Product for assign Projects. 4) Review of Analytical method development, partial validation and API Verification for assign Projects. 5) Maintain GLP in the laboratory as per regulatory requirement. 6) Proper Training to subordinates... 

 ...development as per ICH Guidelines. To perform In-process, routine and stability sample analysis. Perform the analytical method verification / validation as per protocol. Analytical method transfer to QC Laboratory. Documentation as per the GLP requirement. Trouble shooting... 

 ...lab- Main pharma QC laboratory. To analyze the Sample of RM, Validation, FP, in process, Stability for Microbiological analysis by respective...  ...water samples and pure steam condensate samples. Plate / Tube verification and release and on-line data recording Work allocation and... 

 ...and retain samples as per respective MMD-I / BPR/SOP, Process validation/Hold Time/Packing Validation/Stability study as per respective...  ...the time during operation throughout the shift. To ensure daily verification of weighing balance with standard weights. To perform filled... 

 ...with regulatory guidelines. 2) Analyze development and stability samples using validated methods to ensure formulation consistency and shelf-life evaluation. 3) Conduct analytical method verification for API and Finished products as per pharmacopoeia and regulatory... 

 ...stability sample analysis. - Method development and report preparation - Analytical method verification of assigned products. - To perform the forced degradation studies. - To develop and validate the cleaning method. - To Perform partial method validation for new develop method.... 

1) Analytical Method validation on GC for ANDA, Domestic/ROW, Injectable, P2P and others 2) Analytical Method verification on GC for ANDA, Domestic/ROW, Injectable, P2P and others 3) Analytical Method feasibility on GC for ANDA, Domestic/ROW, Injectable, P2P and others 4) Sample... 

 ...Perform Analytical Method validation and verification as per the protocol. Documentation as per GLP requirement. Proper archival of validation books and reports. Troubleshooting during day-to-day analysis with proper instrument care. Response to regulatory and customer queries... 

 ...sample analysis. 3) Method development and report preparation 4) Analytical method verification of assigned products. 5) To perform the forced degradation studies. 6) To develop and validate the cleaning method. 7) To Perform partial method validation for new develop method... 

1)Prepare and Review the ANDA, CTD, Domestic and Export documents of method validation, verification data, protocol & report. 2)Perform analytical method validation/verification as per the protocol. 3)Proper utilization of laboratory equipment and scientist day to day 4)To perform... 

 ...responsbilities would be as mentioned below: Analytical methods validation and report preparation on LCMS (for Nitrosamine impurities,...  ...etc.) Routine and stability sample analysis Analytical method verification of drug products and drug substances on LCMS Key skills required... 

 ...manufacture name (Vendor Name) & TSE-BSE certificate for PQR Compilation. Review for Qualification & validation data for compilation of PQR. To perform continuous process verification of the product. To initiate & review Change Control in LIMS, Deviation & CAPA in EPIQ. Any other... 

 ...reservations, SAP report generation etc. • Verify the environmental parameters like Temperature, RH, pressure difference etc. • Verify Daily verification of weighing balance and daily documentation. • Verify Reconciliation of materials. Stock verification with internal and external... 

1. Method Verification of new HPLC Method for all stages of a new molecule as well as a modified old method as per regulatory requirement. 2. Calibration of HPLC as per SOP and maintenance of HPLC system. 3. Maintaining all analytical records by entering correct details in reports... 

 ...Developed New HPLC Method for all stages of new molecule as well as modified old method as per regulatory requirement. - HPLC Method verification of new developed method. - Calibration of HPLC's as per SOP and maintenance of HPLC Systems. - Trouble shooting during day to day... 

 ...trial review, consumable materials, etc.) for ready reference. To maintain the records of equipment and instruments for calibration/verification and co-ordinate with cross functional team for timely calibration/verification where required. To ensure the calibration tags/... 

 ...reservations, SAP report generation etc. To check the environmental parameters like Temperature, RH, pressure difference etc. Daily verification of weighing balance and daily documentation. Reconciliation of materials. Stock verification with internal and external auditors.... 

1. Method verification of new HPLC method for all stages of new molecule as well as modified old molecule method as per regulatory guidelines. 2. Calibration and maintenance of HPLC systems as per SOP. 3. Maintaining records for all analytical reports by entering all the data... 

 ...conviction certificate) Inspections for WHO ' GMP/Schedule M GMP certification Technical persons approval Technical person application verification. - Liaison with CDSCO, West Zone, Form 29 Export licenses Loan license Manufacturing licence renewal for all plants Wholesale... 

 ...vendor payments Principal Tasks and Responsibilities: 1. Negotiation Ensure Quotations from different vendors are arranged as per SOP Verification of Comparative Analysis and negotiation Finalize the price considering budget, required quantity and delivery on time considering... 

 ...condition in all for said areas are within acceptable range at all the time during operation throughout the shift. To ensure daily verification of weighing balance with standard weights. To perform filled volume & weight method and leak test as per MMD-I & SOP. To perform sampling... 

 ...etc. To prepare SOP and manage the documents. To investigate incidence, OOC and take appropriate CAPA. To perform the calibration, verification and maintenance of instruments. To ensure compliance related GLP-activity in QC. Participate to complete the training for new comers... 

 ...various regulated and less regulated markets. - Preparation of LOA's, CEP LOA's and declarations for various customers and authorities. - Preparation and review of regulatory guidelines for internal reference purpose. - Verification of current monograph during DMF filing.... 

 ...Developed New HPLC Method for all stages of new molecule as well as modified old method as per regulatory requirement. - HPLC Method verification of new developed method. - Trouble shooting during day-to-day analysis and discuss with R&D people of respective project. -... 

 ...Responsibilities: 1. P2P Process Management: Manage the entire Purchase to Pay lifecycle: requisition, PO generation, goods receipt, invoice verification, and payments. Oversee SAP/ERP system transactions to ensure accurate and real-time processing. Monitor and improve P2P KPIs (PO... 

 ...Major purpose of the Job: 1) To developed Analytical Method Development, Routine analysis and Validation by GC & GC-MS 2) To maintain and observe cGLP and cGDP in working environment in GC & GC-MS. 3) Timely respond development of the Regulatory Queries of products. 4) Preparation... 

 ...like SOP, Batch Manufacturing Record, Sampling Protocol, Hold time study protocol/ report, stability study protocol/report, Process validation protocol and Report for the scale up, exhibit and validation batches. To provide technical support for change management, investigations... 

 ...Follow cGMP and GLP practices in Quality Control Lab. To follow safety procedure in qc department. To analyze the Sample of in process validation and finish product on instrument such HPLC, GC, UV, FTIR etc. by following test procedure. To attend the training as per schedule.... 

 ...prepare and review documents like SOP, Sampling Protocol, hold time study protocol/ report, stability study protocol/report, Process validation protocol and Report for the scale up, exhibit and validation batches. To initiate change management, CAPA and Deviations, and... 

 ...Refrigerator and thermometer etc. 6) Preparation and revision of Analytical laboratory's SOP. 7) Issuance and Maintain the records of LNB for validation group, development groups. 8) Issuance and Maintain the records of MRS for development groups. 9) Indent generating of all...