583 Executive Jobs - Page 4

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 & GC-MS calibration report. Trouble shooting during day to day analysis with proper instrument care. Taking care of PM of all the instrument of Analytical GC & GC-MS. Routine analysis support to GC; GC-MS; DSC & TGA

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 Export, Regulatory agency and Domestic market. Preparation of Specification and Standard Test Procedures for Drug controller general of India permission for Domestic market and Export market. Preparation of Specification and Standard Test Procedures for Food and drug administration permission for Domestic market. To coordinate with Formulation and development, Quality Control and Regulatory Agency Taking the Backup record of Raw material, Finished Product Specification and Standard Test Procedures.

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

" 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 online documentation. To do any other Work assign by HOD."

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 preventive maintenance, filter replacement, pump changeover, and to ensure execution as per defined schedule. To help QA team in equipment validation/qualification, and review of concerned documents. To ensure effective engineering support to help all the production facilities located at Dholka.To maintain safety practice during plant operation and maintenance.

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.

"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 activities. To prepare and update Annual Validation Master Planner and Equipment Matrix of all Blocks. To prepare, review, execute and compile the protocol and report of Transportation Validation. To Performed FAT(Factory Acceptance Test), SAT(Site Acceptance Test). Coordination with cross functional teams for smooth conduction of validation activities with respect to: Equipment Qualification / Re-Qualification, Validation / Re-Validation HVAC System Validation and Utility Validation Temperature Mapping Study of critical area To initiate and review change control, deviation and CAPA To prepare, review protocol and reports and execute activity related to Aseptic Process Simulation (Media fill) Studies Any other jobs assigned from time to time."

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, chamberization and legalization, which forms an important part of dossier Arrangement of Samples, Packing Material, Impurities, Reference Standards as per MOH requirement Preparation of COPP’s (Certificate of Pharmaceutical Product) and FSC submit to Local FDA approvals Any other assignments as specified by the reporting authority from time to time

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 finished goods to distributors, C&F agents, or export destinations. Liaise with transporters, courier agencies, and freight forwarders. Prepare and verify shipment documents including invoices, packing lists, COAs, MSDS, etc. Vendor & Supplier Management Maintain relationships with existing suppliers and evaluate new suppliers based on quality, cost, delivery, and service. Support vendor qualification audits in collaboration with QA/QC. Compliance & Documentation Ensure SCM activities adhere to cGMP, GDP, and other regulatory requirements. Maintain records as per SOPs and support internal/external audits. Coordination & Reporting Work closely with production, QA/QC, and finance teams for smooth SCM operations. Prepare and present periodic reports on procurement, inventory status, and supply chain performance.

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.

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 productivity and effectiveness. Collaborate with senior analysts to create and refine regular MIS reports for various teams, especially sales, helping them track performance against targets. Sales Force Effectiveness Analysis Analyze sales data to evaluate sales force effectiveness, providing insights into areas such as territory performance, quota attainment, sales activities, and sales rep efficiency. Develop and monitor KPIs for the sales team, such as sales growth, customer acquisition, and retention, and support the optimization of sales strategies. Assist in segmenting sales data to assess the impact of sales initiatives, campaigns, and training programs on sales force productivity. Data Analysis & Insights Assist in analyzing data trends, identifying patterns, and providing basic insights for decision-making in sales and operational areas. Use Excel, BI tools, or other analytics platforms to generate ad-hoc reports as needed. Prepare reports and data visualizations to highlight key findings for the sales management team, supporting sales strategy and initiatives. Process Improvement & Automation Assist in improving data collection and reporting processes to enhance efficiency and accuracy. Help automate manual data entry and reporting tasks to streamline workflows, especially in sales tracking and reporting. Identify opportunities to simplify and standardize data reporting practices related to sales performance across the organization. Collaboration & Support Work closely with the sales, finance, and operations teams to understand their data needs and provide relevant reports that help drive sales effectiveness. Provide analytical support to sales management for decision-making related to territory management, incentive plans, and performance tracking. Assist in the preparation of presentations and reports for senior management and sales teams, showcasing sales performance trends and effectiveness. Documentation & Compliance Maintain accurate documentation for all data management and reporting procedures related to sales performance. Ensure compliance with internal standards and data governance policies to ensure the integrity and security of business data.

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 finished goods to distributors, C&F agents, or export destinations. Liaise with transporters, courier agencies, and freight forwarders. Prepare and verify shipment documents including invoices, packing lists, COAs, MSDS, etc. Vendor & Supplier Management Maintain relationships with existing suppliers and evaluate new suppliers based on quality, cost, delivery, and service. Support vendor qualification audits in collaboration with QA/QC. Compliance & Documentation Ensure SCM activities adhere to cGMP, GDP, and other regulatory requirements. Maintain records as per SOPs and support internal/external audits. Coordination & Reporting Work closely with production, QA/QC, and finance teams for smooth SCM operations. Prepare and present periodic reports on procurement, inventory status, and supply chain performance.

"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 management, investigations of deviations, CAPA identification and QMS related activities at plant. To review and approve documents like SOP,"

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 for assessment and prepare regulatory submission for authorities and customers

" 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."

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 price considering budget, required quantity and delivery on time considering lead time. Vendor Development, to have an alternate source Advise team to select the items for alternate vendor i.e. for additional source/quality improvement/price etc. as an when required Primary selection of vendor for new development by team. Discussion with new vendor for their capabilities, plants, terms etc. Ensure approvals of QA, QC, Plants for submitted Sample Vendor audit if required & negotiations Arrange commercial lot Market Information Contacts with vendor for new development Newsletters, internet etc. Visit to the vendor premises for latest update Visit to concern trade fare/seminar etc.

" 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 online documentation. To do any other Work assign by HOD."

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

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 seniors/purchase. Ensure compliance to cGMP requirements & Good Engineering Practice requirements besides other statutory laws, rules and regulations. To maintain all the records related to plant maintenance function. To maintain safety practice during operation and maintenance.

Greetings and welcome visitors Manage Front Desk Handle phone calls Manage conference rooms Maintain Records Perform administrative task

Production Supervision of production & maintenance activities of respective shift. To ensure that every raw material used is of right quality (approved from QC, having reference Number) and quantity (verifying the weights, if required by re weighing) in every batch Automation/DCS knowledge required to run the plant in all 3 shifts. To ensure all liquid charging through automation/DCS system. To ensure all solid charging through PTS (Powder Transfer System). To ensure all monitoring through DCS system. To ensure 100% implementation of process conditions for batch as per BPRs. To take instruction from managers for batch charging / monitoring & to execute. To ensure maximum utilization of plant equipment & manpower in respective shift To report any deviation / discrepancy in plant / process to his to reporting manager. To ensure completion of batches as per plan. To do SAP transaction related to production module. Documentation : To ensure to have online completion documents with respect to his shift. To check critical operation with respect to BPR and to verify the related document. Quality : To ensure that instructions in BPRs are followed judiciously To ensure Intermediates / FP produced is as per quality specification To guide / train workmen / trainees / contract workmen in Finished Powder Processing Section. To ensure very high standards of housekeeping in plants and FP areas. cGMP : To ensure proper calibrations of pH meters & weighing balance as per SOP. To ensure timely updation of equipment status board Ensure BPRs of ongoing batches are available at specified places near equipment and are online with production To ensure on line completion of equipment usage log & documentation. To ensure labeling of HDPE / Fiber drums, hose pipes etc. used in respective batch processing. Safety : To ensure awareness to MSDS To ensure innertization before charging of any solvents in reactor. To educate / train / supervise workmen / Trainees / contract workmen in safe handling of chemicals and equipment so as to prevent accidents To ensure the operators are aware / trained in usage of PPE To coordinate with EHS for various safety permits Wastage Avoidance / Reduction : To ensure no spillage of solvents & wastage of material. To ensure closing of valves for utilities supplies when not required (cross check when operation is complete) Switching of reactor and plant lamps when not required Training : To train operators & subordinate on Safety / Quality / wastage reduction To guide / train workmen / trainees in Finished Powder Processing Section. Inter departmental co-ordination : To coordinate with QA department for Good Document Practice. To coordinate with QC department for getting analysis report. To coordinate with Engg Service for maintenance related work. To coordinate with EHS for safety and environment related issues. To coordinate with HR for Manpower related issues.

Procurement Coordination Raise and process purchase orders for raw materials, packaging materials, and other items as per requirements. Follow up with suppliers for on-time delivery and resolve any supply-related issues. Coordinate with QA, QC, and stores for GRN and material clearance. Inventory Management Monitor and maintain optimal inventory levels for RM/PM/FSM (Raw/Packaging/Finished Stock Material). Reconcile stock regularly with warehouse and update ERP records. Work with production planning to avoid stock-outs or excess inventory. Logistics & Dispatch Coordinate with transporters for dispatch planning and delivery of finished goods to customers/C&F. Track shipments and resolve logistics-related challenges. Documentation & Compliance Ensure proper documentation for inward and outward materials. Maintain supplier and product-wise documentation for audit readiness. Adhere to regulatory and GMP/GDP compliance requirements. Coordination & Communication Coordinate between internal departments like QA/QC, Production, Stores, and Finance. Communicate with vendors for order status, quality issues, or delays.

To supervised all activity of shop floor of production department. To handle the men power as per shift. To handle the shift as per production planning. To handle the dispensing activities. To supervised the manufacturing area, autoclave area, vial washing and depyrogenation tunnel and filling related activities. To handle the troubleshooting of production area with the help of supporting department. To ensure calibration certificates of all measuring instruments comply with norms. To check hygienic condition of the workmen before entering to aseptic area and maintain record. To check and ensure that aseptic area workmen are following entry exit procedure properly. To check and ensure that pressure differential of the production area are within limit. To perform operation of various equipment, installation and qualification at production. To check on line in process parameter like temperature, RI-I, 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. are as per respective SOP. To ensure plant wise cGMP compliance. To check and ensure Good documentation practice. To monitor man and material movement In production area.

Supervision of production & maintenance activities of respective shift. To ensure that every raw material used is of right quality (approved from QC, having reference Number) and quantity (verifying the weights, if required by re weighing) in every batch. To ensure 100% implementation of process conditions for batch as per BPRs. To take instruction from managers for batch charging / monitoring & to execute. To ensure maximum utilization of plant equipment & manpower in respective shift. To report any deviation / discrepancy in plant / process to his to reporting manager. To ensure completion of batches as per plan. To do SAP transaction related to production module. Documentation : To ensure to have online completion documents with respect to his shift. To check critical operation with respect to BPR and to verify the related document. CGMP : To perform verification of pH meters & weighing balance as per SOP. To ensure timely updation of equipment status board Ensure BPRs of ongoing batches are available at specified places near equipment and are online with production. To ensure on line completion of equipment usage log & documentation. To ensure labeling of HDPE / Fiber drums, hose pipes etc. used in respective batch processing. CGMP : To perform verification of pH meters & weighing balance as per SOP. To ensure timely updation of equipment status board

Documentation To prepare SOP’s/ URS/ BPR/ Protocol/ Investigation report for regulatory compliance as per available procedure/practice. Ensure that all documents / records required for Regulatory Compliance are maintained properly. Ensure old records are archived properly and are retrievable. To check online filling of document & online submission to QA department. Raise change control/ Deviation/ CAPA in OASIS LIMS. To support SAP transaction in production module as & when required. Raise indents for Consumables, parts, Stationary and Spares required for the plant. To ensure for high standards of housekeeping in plants. To maintain all records and documents as per GDP/SOPs. To take lead in audit preparedness and report to factory manager in case of any deviation. To maintain training records of employees in respect of training SOP. Production To perform the role of production officer/executive as and when required. Cross Functional Department To coordinate with QA, department for compliance. To coordinate with QC, PD Lab, Engineering and HR etc. for GMP Compliance. To coordinate with EHS for safety and environment related audits.