274 Jobs in Dholka - Page 3

To operate the CVC Bulk packing machine as per the norms of cGMP To supervise the machine activity as per the standard output with GMP requirements To carryout in process checks during packing machine activities To arrange packing materials as per shift plan & planning for next shift packing materials To minimize the rejections during packing operation To maintain online and offline packing activity along with time management To ensure timely transfer of finished goods to the BSR

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. are...

1. Preparation and submission of registration and re-registration dossiers as per country requirements of ROW (Preferable Russia, CIS countries and WHO) 2. Arrangement for indent of Samples, Packing Material specimen, Impurities, Reference Standards as per submission requirement. 3. Query evaluation and submission with respective countries requirement within the required time frame. 4. Establish coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. 5. Post approval activities: Submission of variations to the terms of marketing authorizations for finished products as per respective variation guideline. 6. Pre...

Coordinate the distribution of products to various destinations, ensuring timely and accurate deliveries. Monitor inventory levels and collaborate with warehouse teams to maintain stock accuracy. Liaise with transporters, vendors, and internal departments to schedule and track shipments. Maintain records of all distribution-related activities including dispatches, deliveries, and returns. Optimize distribution processes for cost-efficiency and timeliness. Prepare and analyze distribution reports (e.g., delivery timelines, transport costs). Ensure compliance with company policies, safety standards, and regulatory requirements. Resolve issues related to delivery delays, product damages, or inv...

Maintain Forecast Accuracy Finalize the forecast for next 3 month after discussion with marketing team. Maintain product availability against forecast. Closely Co-ordinate with support function and Ach the goal. Manage inventory planning. Generate the production plan for next 3 month based on forecast / requirement. Ensure Physician sample availability as per time line. Launch of NPD products after discussion with cross function team. Every Monday discuss with marketing team for weekly availability. Generate the P2P products indent based on requirement. Weekly discuss with supply planning and P2P team for availability. To provide technical support for change management, investigations of dev...

Major Purpose of the Job: - Analytical Method Development by HPLC for all Project. - Routine HPLC Analysis for Raw Material, Intermediate, in process and Final API as per the Specification and Standard test procedure. - Calibration of HPLC system. - To maintain GLP in working environment. - Regularly co-ordination with project scientist. - Preparation of analytical data and submit for review. Principal Tasks and Responsibilities: - Routine HPLC Analysis for Raw Material, Intermediate, in process and Final API as per the Specification and Standard test procedure. - Developed New HPLC Method for all stages of new molecule as well as modified old method as per regulatory requirement. - HPLC Met...

1. Working on Unit operations related to downstream processing during Drug Substance (DS) manufacturing. 2. GMP documentation related to DS manufacturing like batch records, equipment usage, facility monitoring. 3. Preparation of documents like SOPs, MMDS and QMS related documents like change control, deviation, CAPA, risk assessment etc. 4. Monitoring of manufacturing facility and keep it cGMP compliant 5. Involvement during regulatory audit preparation 6. Co-ordination with cross functional teams like QC, QA, Maintenance, Warehouse, Injection etc. 7. Training and mentoring new joinees 8. Keep the track for calibration and qualification activities, for example for equipment, weighing scale ...

1. Act as Study Director for various Pre-Clinical studies as per guidelines 2. Conduct, schedule & report toxicological studies for various products in pre-clinical studies 3. Conduct Pharmacological evaluation of various pharmaceutical products 4. Preparation of SOP & documentation as per guidelines 5. Ensuring facility readiness as per regulatory guidelines & audits

To prepare and maintain SOPs and documents related to plant preventive maintenance. To conduct routine breakdown maintenance of Main Pharma Block equipment. To follow and implement the PPM schedule for effective execution in the shortest possible time for all equipment, in close coordination with the production department. To allocate maintenance jobs to technicians based on routine breakdown requisitions. To coordinate with interdepartmental staff for any breakdowns or abnormalities in equipment. To provide support for the execution of CAPEX projects related to process equipment. To ensure timely requisition of spares required for preventive and breakdown maintenance, with close follow-up w...

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 preparation and system setup for GC work 5) Analytical method transfer to QC Lab 6) Document work ,Reporting work and GLP activities 7) Ensure Gas cylinders stock and Lab chemical stock 8) Cleaning and Maintenance of laboratory equipment

Position Summary: The Assistant Vice President (AVP) Project Management will lead and oversee end-to-end project activities across a portfolio of initiatives, with a strong focus on pharmaceutical products for both domestic and regulated international markets. This role requires proactive engagement with cross-functional teams, strong governance over timelines, costs, risks, and resources, and a commitment to elevating project management practices across the organization. The AVP will serve as a key liaison between internal stakeholders, clients, and senior leadership, ensuring successful execution and delivery of strategic initiatives. Key Responsibilities: - Provide strategic project manag...

1. Data review of MD, MV, and study project 2. Data review of Daily performance check of Bio analytical equipments and external and internal calibration data 3. SOP preparation, Report Preparation, Report review, STP,MVP,BSP review 4. To perform System audit, sponsor audit and Regulatory audit 5. Documentation as per GLP and GDP

Role Summary: Monitor and track project activities from inception to closing. Proactively interact with managers within the organization during the course of the project. Working towards increasing the project management competency and capability within the organization as a whole and involved in both tacit and explicit knowledge transfer and integration initiatives. Works closely in collaboration with other roles, such as organizational managers, subject matter expert and those involved in business analysis. Focus on critical project management elements not limited to schedule, cost, resources and risks for each project. Make time to plan thoroughly and prioritize diligently. Principal Task...

- Ensure strict cGMP compliance during the unit operations and for the facilities, documentation, training reports and records for Biologics - Performing the production activities of Biosimilar Drug Substance - Operation of 5L, 100L and 1500 L fermenter - Operation of Protein purification system ( Akta Prime, Akta Pure and Akta Pilot) and TFF system - Operation of all the equipment required for Upstream and Downstream process of Biosimilar Drug Substance - Maintaining records to comply with regulatory requirements. - Monitoring manufacturing processes and in process results of different unit operation - Preparation and review of documents as per regulatory requirement like MMD, SOPs and othe...

Core responsibility related to GLP: Study Personnel (Toxicology & Efficacy studies) - Record raw data accurately and directly and in compliance with Principles of GLP during conduct of activity, verify the data collected, prepare reports and archive these records. - Request for test and reference item and its receipt, safe handling and disposal as per in-house SOPs. - Preparation and labelling of reagents, solutions chemicals and testing samples in the laboratory areas - Wearing appropriate protective clothing and follow all safety precautions - Operation, calibration, cleaning, labelling and maintenance of instruments used for routine activity and maintain these records - Maintain cleanline...

Packaging Material Management Oversee procurement, quality assurance, and inventory control of packaging materials (e.g., blisters, bottles, cartons, foils, labels, shippers). Ensure availability of packaging materials as per production schedules without overstocking. Forecast material requirements and align with sales and production planning. 2. Vendor Development and Management Identify, qualify, and manage suppliers for packaging materials. Negotiate contracts, pricing, and delivery timelines to ensure quality and cost efficiency. Establish strategic partnerships with key suppliers. 3. Compliance and Regulatory Ensure all packaging materials comply with national and international regulato...

Major Purpose of the Job: - Analytical Method Development by HPLC for all Project. - Routine HPLC Analysis for Raw Material, Intermediate, in process and Final API as per the Specification and Standard test procedure. - Calibration of HPLC system. - To maintain GLP in working environment. - Regularly co-ordination with project scientist. - Preparation of analytical data and submit for review. Principal Tasks and Responsibilities: - Routine HPLC Analysis for Raw Material, Intermediate, in process and Final API as per the Specification and Standard test procedure. - Developed New HPLC Method for all stages of new molecule as well as modified old method as per regulatory requirement. - HPLC Met...

1. Procurement Operations Ensure timely purchase of raw and packaging materials as per production requirements. Issue purchase orders, track deliveries, and ensure timely inward of materials. Coordinate with production planning and inventory control (PPIC) to avoid shortages. 2. Vendor Management Identify, qualify, and develop vendors for key materials. Maintain vendor relationships and monitor performance (delivery, quality, cost). Handle negotiations to achieve cost savings and favorable terms. 3. Inventory Coordination Monitor inventory levels and initiate timely replenishment. Ensure minimum stock levels are maintained for uninterrupted production. Coordinate with stores and warehouse fo...

Follow cGMP and GLP practices in Quality Control Lab. To analyze the Sample of raw material on non-chromatographic instrument such as FTIR, UV, Polarimeter, KF, Autotitrator etc. by following test procedure. 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 online documentation. To do any other Work assign by HOD. Follow cGMP and GLP practices in Quali...

1) Based on production requirement generate the production plan for next 3 month. 2) Run MRP for next 3 month in System (SAP) 3) Share the shortages to RM / PM based on requirement to Purchase team. 4) Discuss and coordinate with purchase team for timely supply RM / PM 5) Discuss with Production team for scheduling of products. 6) Delivery has to completed for M0 for ISBU / USBU on 22nd and for BSBU on 25th 7) Prepare the plan Vs Actual on daily basis. 8) Generate the LL requirement separately after discussion with LL team. 9) Closely coordinate with cross function department for Ach goal. 10) Daily discuss with Production / QC and purchase team for ach daily schedule. 11) To provide technic...

To perform the Technology transfer of Product from R&D to Manufacturing Site. 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 finalize batch sizes of scale up, exhibit and commercial batches to meet the equipment capacities and regulatory requirements with consent of R&D and production. To prepare/review relevant documents 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 val...

1. Strategic Procurement Management Develop and execute procurement strategies aligned with production and compliance needs. Plan sourcing of APIs, excipients, packaging materials, lab chemicals, and consumables. Ensure procurement planning supports uninterrupted manufacturing and new product launches. 2. Vendor Development and Management Identify and qualify new vendors, ensuring they meet regulatory and GMP standards. Conduct vendor audits (in coordination with QA/Regulatory teams). Establish long-term supply agreements with key suppliers to ensure continuity and quality. Monitor supplier performance (delivery timelines, quality, cost competitiveness). 3. Regulatory and Quality Compliance ...

To perform the Technology transfer of Product from R&D to Manufacturing Site. 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 finalize batch sizes of scale up, exhibit and commercial batches to meet the equipment capacities and regulatory requirements with consent of R&D and production. To prepare/review relevant documents 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 val...

Responsible for receipt, storage, issuance, submission, analysis, reconciliation and discard of the received samples, control samples, chemicals, solvents, buffers, reagents, kits, antibodies, consumables and other items of biotech products. Follow and maintain quality system and procedure in lab, prepare and maintain all required documents as per GLP norms and Regulatory Requirement. To ensure handling, calibration, maintenance, cleaning and documents related to operation, calibration, breakdown of the instruments as per SOPs. Maintain required cells/cell line, Sub culturing of cells and performance of the cell growth assay. Mainly responsible for maintenance, procurement, cleaning, handlin...

Responsible manufacturing activity of Liquid Bulk, Filling Machine, Bottle washing machine change over, & operation as per schedule. Responsible for change over & operation of Labeling, Auto cup, Sticker labelling, Auto cartooning & 2d barcoding machine. To issue primary & secondary packing material from store & documentation work as per supervisor instruction Machine & Area cleaning in Liquid Area. To manufacture Liquid Bulk as MMD I as per instruction of supervisor To manufacture Liquid Bulk as MMD I as per instruction of supervisor To change over of Bottle washing machine, Filling & Capping Machine as per schedule given by supervisor. To change over of Auto cup pressing machine, sticker l...