15 Jobs in Gaddapotharam

Job Responsibilities: Absorb new product technologies and identify opportunities for cost improvements in existing products. Monitor unit operations and analyze batch process abnormalities, recommending solutions with site leader guidance. Support scale-up of API products from kilo lab to plant scale. Prepare Process Flow Diagrams (PFD), Process & Instrumentation Diagrams (P&ID), and Equipment Flow Diagrams (EFD). Develop process cycle times and map process equipment for new products using geometric capacities. Minimize solvent losses in production and optimize solvent recovery processes. Analyze incidents, propose Corrective and Preventive Actions (CAPA) to prevent recurrence. Lead the scal...

a. Should have experience in the development of Solid Oral, Liquid and Sterile Dosage forms. b. Should lead innovative or differentiated projects to support business goals. c. Should have experience in the development of potent and non-potent product. d. Excellent communication and documentation skills are must. e. It is preferred to have an experience of working with international customers. f. Should be well versed with international regulatory requirements.

a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must. Excellent knowledge on product development and clinical studies

a. Should have experience in the development of Solid Oral Dosage forms for general and potent products. b. Should be well versed with various regulatory guidelines. c. Should have through knowledge about fundamentals of pharmaceutical development. d. Good communication skills are must. Development of Solid Oral Dosage forms for general and potent products

Manage the technology transfer process for established products, ensuring robust and compliant manufacturing processes e.g. implementation of new API sources. Write, review, and maintain regulatory response documents, justification reports, and risk assessments related to technology transfer activities. Oversee the preparation and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for smooth transfer and manufacturing. Review process validation protocols and reports. Coordinate with R&D, production, quality assurance, and regulatory teams to ensure alignment on project deliverables and timelines. Troubleshoot and optimize manufacturing processes addressing deviatio...

Handle day-to-day IT support tickets related to desktops, laptop, mobile devices, printers, and peripheral hardware Troubleshoot and resolve issues with Windows OS, basic software applications, network connectivity, and user access Administer and manage Active Directory, user access controls, system privileges, and security Manage VLAN configuration and monitoring, supporting network segmentation and troubleshooting Perform routine preventive maintenance of IT hardware and support IT asset inventory management Coordinate with vendors for warranty replacements, hardware procurement, and service requestsSupport IT onboarding/offboarding activities such as system provisioning, email account set...

Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines. Europe Market in Life Cycle Management

Sourcing and procurement of APIs and their impurities, and developing new or alternative vendors. API indents and planning as per the monthly production or PD schedule, coordinating with the PPIC Team and Warehouse team. Conducting due diligence audits of API facilities. Coordinating with the Regulatory and Quality Teams to arrange responses from vendors for queries and investigations. Experience in making monthly purchase statements, generating purchase orders, and work orders, as well as generating purchase performance reports on a bimonthly basis. Evaluating CDMOs for the synthesis of new APIs. Sound knowledge in vendor qualification and 21 CFR compliance, as well as licenses related to A...

a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must. Excellent knowledge on product development and clinical studies

Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines. Europe Market in Life Cycle Management

Handle day-to-day IT support tickets related to desktops, laptop, mobile devices, printers, and peripheral hardware Troubleshoot and resolve issues with Windows OS, basic software applications, network connectivity, and user access Administer and manage Active Directory, user access controls, system privileges, and security Manage VLAN configuration and monitoring, supporting network segmentation and troubleshooting Perform routine preventive maintenance of IT hardware and support IT asset inventory management Coordinate with vendors for warranty replacements, hardware procurement, and service requestsSupport IT onboarding/offboarding activities such as system provisioning, email account set...

a. Should have experience in the development of Solid Oral Dosage forms for general and potent products. b. Should be well versed with various regulatory guidelines. c. Should have through knowledge about fundamentals of pharmaceutical development. d. Good communication skills are must. Development of Solid Oral Dosage forms for general and potent products

a. Should have experience in the development of Solid Oral, Liquid and Sterile Dosage forms. b. Should lead innovative or differentiated projects to support business goals. c. Should have experience in the development of potent and non-potent product. d. Excellent communication and documentation skills are must. e. It is preferred to have an experience of working with international customers. f. Should be well versed with international regulatory requirements.

Manage the technology transfer process for established products, ensuring robust and compliant manufacturing processes e.g. implementation of new API sources. Write, review, and maintain regulatory response documents, justification reports, and risk assessments related to technology transfer activities. Oversee the preparation and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for smooth transfer and manufacturing. Review process validation protocols and reports. Coordinate with R&D, production, quality assurance, and regulatory teams to ensure alignment on project deliverables and timelines. Troubleshoot and optimize manufacturing processes addressing deviatio...

Sourcing and procurement of APIs and their impurities, and developing new or alternative vendors. API indents and planning as per the monthly production or PD schedule, coordinating with the PPIC Team and Warehouse team. Conducting due diligence audits of API facilities. Coordinating with the Regulatory and Quality Teams to arrange responses from vendors for queries and investigations. Experience in making monthly purchase statements, generating purchase orders, and work orders, as well as generating purchase performance reports on a bimonthly basis. Evaluating CDMOs for the synthesis of new APIs. Sound knowledge in vendor qualification and 21 CFR compliance, as well as licenses related to A...