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0 years
0 Lacs
Dholka, Gujarat, India
On-site
To perform the technology receiving activities and QMS related activities at the manufacturing plant. To perform technology-receiving activities by receiving processes from upstream process development to manufacturing and/or between multiple manufacturing sites. This includes developing and maintaining key SOPs, manufacturing records to support compliance with quality management and regulatory submissions. To perform alternate vendor batch execution, process improvement, change in batch size, trouble shooting at shop floor, equipment change activities of product after technology transfer completion along with production team. To coordinate the development of the manufacturing process with t...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
" Responsible for small volume parenteral manufacturing activities at Dholka premises. To check hygienic condition of the workmen before entering to aseptic area, processing area and compounding area and maintain record. To check and ensure entry exist procedure of workmen with proper gowning and sanitization. To check and ensure that Temperature and differential pressure of the all area is within limit and record it properly. To check on line in process parameters like temperature, RH, fill volume, quality of sealing at specific interval as mentioned in respective MMD-I and SOPs and record the same in BMR To check and ensure that sterilization of the containers, equipment's, utensils etc. a...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Procurement & Sourcing Assist in sourcing of raw materials, excipients, and packaging materials as per production requirements. Raise and process purchase orders (POs) in ERP systems (e.g., SAP). Coordinate with approved vendors to ensure timely delivery and best commercial terms. Maintain procurement records and supplier documentation in compliance with audit norms. Inventory & Material Management Monitor stock levels to ensure optimum inventory without overstocking or stock-outs. Coordinate with production and warehouse teams for material availability and replenishment planning. Conduct regular inventory audits and resolve discrepancies. Logistics & Distribution Ensure timely dispatch of f...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
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 manage an accurate, reliable, efficient and timely review of finished products, in process/ validation, raw material, stability, GLP, Non-routine samples. To ensure timely review of batch audit trail, system audit trail, message center. To ensure review of Logbooks of instrument, equipment’s, columns, standards, impurities etc. To review the COA of finished product in LIMS after the completion of analysis. To ensure the status label updated for the instruments, ...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
1 Ensure Freedom to operate of CPL's product (Formulation) 2 Design a strategy to secure CPL's invention effectively 3 Handling of Patent Prosecution 4 Effective Management of CPL Patent Portfolio 5 Support to New Product Selection Activity
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Ensure Freedom to operate of CPL's product (Formulation) Design a strategy to secure CPL's invention effectively Handling of Patent Prosecution Effective Management of CPL Patent Portfolio Support to New Product Selection Activity
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Major Purpose Of The Job To developed Analytical Method Development, Routine analysis and Validation by GC & GC-MS To maintain and observe cGLP and cGDP in working environment in GC & GC-MS. Timely respond development of the Regulatory Queries of products. Preparation of COA’s. Follow and update periodic Preventive Maintenance & Calibration schedule of GC & GC-MS DSC; TGA instrument. Responsibilities Preparation of NewAnalytical method validation and Method Transfer Protocol and Report as per the current Regulatory requirement. Prepare Protocol of analytical method validation and method transfer report and routine analysis data. Preparation of standard operating procedure. Maintaining GC & G...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Major Purpose: (Exactly spell out key deliveries/results expected from this job) Preparation of New product Specifications and Standard test procedures for ANDA, Export and Domestic markets. Preparation of Routine revision Specifications and Standard test procedures for ANDA, Export and Domestic markets Responsibilities: (Please write all the major jobs that the employee is required to carry out ) Preparation of New product documents and Routine Revision of Raw Material Specifications and Standard Test Procedures for Export, Regulatory agency and Domestic market. Preparation of New product documents and Routine Revision of Finished Product Specifications and Standard Test Procedures for Expo...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
This role would be part of Analytical Research & Development for Formulations Research team. The key responsbilities would be as mentioned below: Analytical methods validation and report preparation on LCMS (for Nitrosamine impurities, NDSRI impurities etc.) Analytical Method development and report preparation on LCMS (for Nitrosamine impurities, NDSRI impurities etc.) Routine and stability sample analysis Analytical method verification of drug products and drug substances on LCMS Key Skills Required Analytical method development by LCMS & validation Trouble shooting of Instruments Impurity maintenance
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
" Follow cGMP and GLP practices in Quality Control Lab. To analyze the Sample of stability on non-chromatographic instrument such as FTIR, UV, Dissolution, DT, Hardness etc by following test procedure. Analysis of Stability Samples as per schedule To attend the training as per schedule. To follow safety procedure in QC department. To receive the samples for analysis and making entry in Inward register. To maintain the Instruments log books related to sample analysis. To analyze the sample and compilation of documents. Responsible for taking of Continuations sheet (CS) and print out Record of analysis (ROA) through LIMS. Responsible for cleaning & monitoring of laboratory. Responsible for onl...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Ensure efficient operation and maintenance of Utility (Boiler, chilling plant, Air compressor, cooling tower and N2 System). To ensure strict compliance of cGMP requirements & Good Engineering Practice requirements besides other statutory laws, rules and regulations. To implement Cost reduction measures in the operation of the Utility. To prepare and maintain SOP and documents related to machine operation and maintenance. To identify probable cause/potential non-conformity to any breakdown/abnormal condition. To perform breakdown maintenance activity as and when applicable. Review machine operation related documents and equipment log books. To prepare schedule for planned activities like pre...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Method verification of new HPLC method for all stages of new molecule as well as modified old molecule method as per regulatory guidelines. Calibration and maintenance of HPLC systems as per SOP. Maintaining records for all analytical reports by entering all the data in raw note book and timely release of analytical report. To maintain analytical data and report.
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
"1. Planning and execution of Validation, Qualification, Re-Qualification and Re-Validation activities pertaining to Manufacturing facility at Dholka site in line with the cGMP requirements of national and international regulatory authorities. To Perform Vendor Management Activity to assure that Vendors are Complying with Cadila SOP on Vendor Management and GMP Requirements in Order to source Quality Materials and Products. To perform the validation exercises of new as well as existing equipment’s, utilities and critical systems. Preparation, Execution, Compilation & Review of qualification and Validation Protocols & Reports. Preparation of SOPs pertaining to qualification and Validation act...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Compilation, review and submission of registration dossiers in the regions of South East Asia Handling of regulatory queries/deficiencies across all the South East Asia countries Submission of Supplements/Variations across all the South East Asia countries Review of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols etc. and Review and approval of Change Controls & Deviations Ensure availability of current guidelines for South East Asia Establish co-ordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within period Submission of various original documents for notarization...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Procurement & Sourcing Assist in sourcing of raw materials, excipients, and packaging materials as per production requirements. Raise and process purchase orders (POs) in ERP systems (e.g., SAP). Coordinate with approved vendors to ensure timely delivery and best commercial terms. Maintain procurement records and supplier documentation in compliance with audit norms. Inventory & Material Management Monitor stock levels to ensure optimum inventory without overstocking or stock-outs. Coordinate with production and warehouse teams for material availability and replenishment planning. Conduct regular inventory audits and resolve discrepancies. Logistics & Distribution Ensure timely dispatch of f...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
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 in QC department. To attend the training as per schedule. To receive the samples for analysis and making entry in Inward register. To maintain the Instruments log books related to sample analysis. To analyze the sample and compilation of documents. Responsible for taking of Continuations sheet (CS) and print out Record of analysis (ROA) through LIMS. Responsible for online documentation. To do any other Work assign by HOD.
Posted 3 months ago
0 years
0 Lacs
Gandhinagar, Gujarat, India
On-site
Data Collection & Management Collect, organize, and maintain data from various internal sources (e.g., financial, operational, sales, and customer data). Ensure the accuracy and consistency of data by verifying and cleaning the data sets. Support data entry, database maintenance, and ensure data is stored and updated correctly in the system. Reporting & Dashboards Prepare and generate daily, weekly, and monthly reports on key business metrics, with a focus on Sales Force Effectiveness (e.g., sales productivity, sales cycle, conversion rates, etc.). Create and maintain dashboards to track the performance of the sales team, identifying key performance indicators (KPIs) related to sales product...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Procurement & Sourcing Assist in sourcing of raw materials, excipients, and packaging materials as per production requirements. Raise and process purchase orders (POs) in ERP systems (e.g., SAP). Coordinate with approved vendors to ensure timely delivery and best commercial terms. Maintain procurement records and supplier documentation in compliance with audit norms. Inventory & Material Management Monitor stock levels to ensure optimum inventory without overstocking or stock-outs. Coordinate with production and warehouse teams for material availability and replenishment planning. Conduct regular inventory audits and resolve discrepancies. Logistics & Distribution Ensure timely dispatch of f...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
"1) Based on production requirement generate the production plan for next 3 month. Run MRP for next 3 month in System (SAP) Share the shortages to RM / PM based on requirement to Purchase team. Discuss and coordinate with purchase team for timely supply RM / PM Discuss with Production team for scheduling of products. Delivery has to completed for M0 for ISBU / USBU on 22nd and for BSBU on 25th Prepare the plan Vs Actual on daily basis. Generate the LL requirement separately after discussion with LL team. Closely coordinate with cross function department for Ach goal. Daily discuss with Production / QC and purchase team for ach daily schedule. To provide technical support for change managemen...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil and ROW market Preparation of query response of drug substance for various and less regulated markets and customers. Preparation of applicant part and closed part for various authorities for different customers. Preparation of annual updates and amendment of drug master files US via ESG, ASMF via CESP, KDMF via MFDS Korea, Preparation and submission of CEP applications and responses to EDQM via CESP. Preparation of CEP LOA’s & LOA’s and declarations of various customers and authority. To collect and evaluate scientific data...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
" 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 in QC department. To attend the training as per schedule. To receive the samples for analysis and making entry in Inward register. To maintain the Instruments log books related to sample analysis. To analyze the sample and compilation of documents. Responsible for taking of Continuations sheet (CS) and print out Record of analysis (ROA) through LIMS. Responsible for online documentation. To do any other Work assign by HOD."
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Major Purpose Of The Job Negotiation with vendor for lowest price. New vendor development for alternate source. SAP operation. Market information. Resolving day to day issues with internal and external customers. Team work. Cross functional meeting with internal customers for update and issue resolution. Follow up with vendors for delivery / quotation and if any requirement for our internal customers Ensure timely delivery of primary & secondary packaging materials for each location Ensure timely vendor payments Principal Tasks And Responsibilities Negotiation Ensure Quotations from different vendors are arranged as per SOP Verification of Comparative Analysis and negotiation Finalize the pr...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
" Follow cGMP and GLP practices in Quality Control Lab. To analyze the Sample of stability on non-chromatographic instrument such as FTIR, UV, Dissolution, DT, Hardness etc by following test procedure. Analysis of Stability Samples as per schedule To attend the training as per schedule. To follow safety procedure in QC department. To receive the samples for analysis and making entry in Inward register. To maintain the Instruments log books related to sample analysis. To analyze the sample and compilation of documents. Responsible for taking of Continuations sheet (CS) and print out Record of analysis (ROA) through LIMS. Responsible for cleaning & monitoring of laboratory. Responsible for onl...
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
Working on Unit operations related to downstream processing during Drug Substance (DS) manufacturing. GMP documentation related to DS manufacturing like batch records, equipment usage, facility monitoring. Preparation of documents like SOPs, MMDS and QMS related documents like change control, deviation, CAPA, risk assessment etc. Monitoring of manufacturing facility and keep it cGMP compliant Involvement during regulatory audit preparation Co-ordination with cross functional teams like QC, QA, Maintenance, Warehouse, Injection etc. Training and mentoring new joinees Keep the track for calibration and qualification activities, for example for equipment, weighing scale and standards etc
Posted 3 months ago
0 years
0 Lacs
Dholka, Gujarat, India
On-site
To prepare and maintain SOP and documents related to Plant preventive maintenance. To conduct routine breakdown maintenance of Main Pharma Block equipment’s. To follow and implement PPM schedule for effective implementation in shortest duration of time for all equipment’s in close co-ordination with production dept. To allocate maintenance job to all the technicians with routine breakdown requisition. To co-ordinate with inter department staff for any breakdown or any abnormality in equipment’s. To provide support to Execution of CAPEX project of process equipment side. Ensure timely indenting of spares required for preventive maintenance / breakdown maintenance with close follow up with sen...
Posted 3 months ago
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