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. Respon...
Compliance to cGMP and other regulatory requirement. • To monitor the daily packing activates in primary packing in with compliance of cGMP norms. • To execute packing inputs as per shift plan in Advanced & achieve it. • Ensure compliance o...
Compilation, review and submission of registration dossiers in the regions of Latin America /MENA countries. Handling of regulatory queries/deficiencies across all the Latin America countries. Submission of Supplements/Variations across all...
To carry out in process checks during Granulation activities. •To arrange batches as per shift plan and planning for next shift material to make easy to perform Granulation activity. •To maintain document (BMR) as per cGMP and also filled a...
Follow cGMP and GLP PRACTICES. • To ensure current good laboratory compliance and ensuring all SOPs related to Quality Control laboratory are prepared and reviewed / implemented properly. • To follow safety Procedure in QC department. • To ...
Management of stores activities for Raw materials. Receipt of Raw materials. To ensure Quality and cGMP compliance of the products being manufactured. Responsibilities: 1.Receipt of Raw Material for main Pharma stores. 2.To check the enviro...
NeR & ReR Dossier preparation for AFRICA including FWA countries- Dossier preparation as per current regulatory guideline within given time period Client and MOH Queries- Query handling which will be received from client and MOH of differen...
"• Follow cGMP and GLP practices in Quality Control Lab. • To analyze the Sample of In process validation and finish product on non-chromatographic instrument such as FTIR, UV, Dissolution, DT , Hardness etc by following test procedure. • T...
- Carry out repair and maintenance of all machines in the parenteral manufacturing and aseptic areas. - Operate all equipment in the parenteral manufacturing area, including PFS filling, vial and ampoule filling, Autoclave, DHS, TS, and all...
"• Follow cGMP and GLP practices in Quality Control Lab. • To analyze the Sample of Raw Material on instrument such HPLC, GC, LCMS etc. by following test procedure. • To attend the training as per schedule. • To follow safety procedure in Q...
Compliance to cGMP and other regulatory requirement. •To monitor the daily packing activates in Secondary packing in with compliance of cGMP norms. •To execute packing inputs as per shift plan in Advanced & achieve it. •Ensure compliance of...
"• 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 procedu...
To plan daily coating activity per norms of cGMP. •To supervise cleaning and coating activity as per requirement in Cephalosporin block. •To check carry out in process checks during coating activities. •To arrange batches as per shift plan ...
Principal task and responsibilities: 1.All the maintenance activity in AC/dx units installed at Dholka facility. 2.Execution of preventive maintenance for all AC/dx units, Refrigerator, Cold Room, Cold Chamber, Deep Freezer (-20°C) as per p...
"• Follow cGMP and GLP practices in Quality Control Lab. • To analyze the Sample of stability on instrument such HPLC, UV, FTIR etc. by following test procedure. • Analysis of Stability Samples as per schedule • To follow safety procedure i...