Department DetailsRole Summary1.Hands on experience in formulation development for biologics and/or injectables 2. Proficient in using analytical instruments like HPLC (SEC, IEX, RP), UPLC, CE SDS, UV spectrometry, Solo VPE, Osmometer, KF moisture analyzer and interpretation of results for successful…
Department DetailsRole SummaryJob Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.Responsible for: Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of…
Department DetailsRole SummaryJob Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.Responsible for: Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of…
Department DetailsRole Summary1. Candidate should have experience on maintenance of Automatic Vial washing Machine, Continuous sterilizer(Tunnel), Vial and Cartridge Filling machine and Sealing Machine. 2. Candidate should have experience on maintenance of Autoclave, GMP washer and other pharmaceutical operation equipment's.…
Department DetailsRole Summary1.Hands on experience in formulation development for biologics and/or injectables 2. Proficient in using analytical instruments like HPLC (SEC, IEX, RP), UPLC, CE SDS, UV spectrometry, Solo VPE, Osmometer, KF moisture analyzer and interpretation of results for successful…
Department DetailsRole Summary1. Author & Review for Tech Transfer documents preparation for CMOs (Wyzon, Virchow ERIS, other CMOs & B1, B2 L1). 2. Development & PPQs batches execution support to CMOs Mfg. & Tech transfer team. 3. Author Product impact…
Department DetailsRole Summary Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of activities and deliverables provided by other cross functional teams to support the development, approval, and long term planning of biosimilar…
Department DetailsRole Summary"Primary responsibilities: 1. Execution of routine Re validation of HVAC systems. 2. Coordinating and preparation of URS, DQ, IQ, OQ and PQ along with user and Projects. 3. Preparing of General and Preventive maintenance procedures and Equipment Checklist…
Department DetailsRole Summary1. Develop and implement security policies, protocols and procedures. 2. Control budgets for security operations, monitor expenses and payments. 3. Manage security guarding across BBL multiple offices. 4. Recruit, train and supervise security officers and guards. 5. Support…
Department DetailsRole SummaryImpurity Management for API Synthetic: This position is responsible to ensure that all work required to synthesize the impurities required for various API development program. The role includes planning, delivering on time quantities of required impurities at best…
Department DetailsRole Summary Scheduling, planning, executing, monitoring and control of shift based manufacturing operations. Responsible for the downstream operations for the purification of cell culture processes for the production of monoclonal antibodies Preparation and review of cGMP documents like SOP,…
Department DetailsAccount Manager API commercial INDIARole SummaryThe role holder would be responsible for the following activities in the assigned regions/territories: Sales & Business Development Assist the regional business heads in day to day activities to ensure smooth functioning of the…
Department DetailsRole SummaryTeam member Calibration and validation. Knowledge on calibration of analytical instruments such as HPLC & GC is mandatory. Knowledge on method validation and method transfer is mandatory. Knowledge on Labware LIMS, SAP & Track wise will be an…
Department DetailsRole Summary\xc3\xbc Adherence to CGMP process in day to day activity. \xc3\xbc Ensure Good Documentation Practices and Data integrity policy (ALCOVA++) is followed as per guidelines. \xc3\xbc Receiving of Solvents (Acetonitrile fresh, Acetonitrile (Recovered),Methanol, Isopropyl alcohol,Ethanol,Dimethyl Formamide, DI Methyl…
Department DetailsRole Summary\xc3\xbc Adherence to CGMP process in day to day activity. \xc3\xbc Ensure Good Documentation Practices and Data integrity policy (ALCOVA++) is followed as per guidelines. \xc3\xbc Receiving of Solvents (Acetonitrile fresh, Acetonitrile (Recovered),Methanol, Isopropyl alcohol,Ethanol,Dimethyl Formamide, DI Methyl…
Department DetailsRole Summary1. Candidate should have experience on maintenance of Automatic Vial washing Machine, Continuous sterilizer(Tunnel), Vial and Cartridge Filling machine and Sealing Machine. 2. Candidate should have experience on maintenance of Autoclave, GMP washer and other pharmaceutical operation equipment\'s.…
Department DetailsRole Summary1. Support the manufacturing team and participate/supervise in shift operations (Chromatography, buffer preparation, cleaning equipment, operation of centrifuges, Lyophilizer operation, sterilization of equipment, etc.). 2. To follow the established procedures and adhere to the policies of the company…
Department DetailsQC MicrobiologyRole SummaryHandling of microbiology sectionKey ResponsibilitiesHandling of change controls in Microbiology laboratory. Review of equipment and instruments usage logbooks and other testing data generated in lab Preparation and review of Evaluation and establishment of microbiological specifications reports.Preparation and…
Department DetailsGPP Engineering and maintenanceRole Summary[[1. Candidate should have experience on maintenance of Automatic Vial washing Machine, Continuous sterilizer (Tunnel), Vial and Cartridge Filling machine and Sealing Machine. 2. Candidate should have experience on maintenance of Autoclave, GMP washer and…
Department DetailsRole Summary1. Candidate should have experience on maintenance of Automatic Vial washing Machine, Continuous sterilizer(Tunnel), Vial and Cartridge Filling machine and Sealing Machine. 2. Candidate should have experience on maintenance of Autoclave, GMP washer and other pharmaceutical operation equipment\'s.…
Department DetailsRole Summary1. Develop and implement security policies, protocols and procedures. 2. Control budgets for security operations, monitor expenses and payments. 3. Manage security guarding across BBL multiple offices. 4. Recruit, train and supervise security officers and guards. 5. Support…
Department DetailsRole Summary1. Execution of periodical calibration of instruments as per schedule. 2. Handling shift maintenance activities on round the clock in shifts. 3. Strict adherence to cGMP, GEP and EHS guidelines while carrying out all activities. 4. Attending breakdowns…
Department DetailsRole Summary Knowledge of process equipment maintenance in pharma Knowledge of Utility equipment Perform routine and preventive maintenance on process equipment, Troubleshoot and resolve mechanical, electrical, and pneumatic issues with equipment. Conduct repairs and resolve unplanned equipment downtimes promptly.…
Department DetailsRole Summary1. Candidate should have experience on maintenance of Automatic Vial washing Machine, Continuous sterilizer(Tunnel), Vial and Cartridge Filling machine and Sealing Machine. 2. Candidate should have experience on maintenance of Autoclave, GMP washer and other pharmaceutical operation equipment\'s.…
Department DetailsRole Summary1. To carry out planned preventive maintenance on all plant and equipment aiming to achieve maximum plant availability with a target of zero unplanned downtime. 2. To raise communication memo for Preventive Maintenance. 3. To maintain availability of…
Department DetailsRole SummaryAssistant Manager SAP QM RoleKey Responsibilities Good functional knowledge of standard SAP QM processes in Pharmaceutical Operations. In depth knowledge/ understanding of GMP & Protocols Act as a single point of contact for SAP related queries in SAP…
Department DetailsRole Summary1. Develop and maintain a detailed program plan for various digitization projects, including objectives, scope, deliverables, schedule, budget, and resource requirements. 2. Lead and manage cross functional discussions, track action items, progress and update project managers as required.…
Department DetailsRole Summary1. Candidate should have experience on maintenance of Automatic Vial washing Machine, Continuous sterilizer(Tunnel), Vial and Cartridge Filling machine and Sealing Machine. 2. Candidate should have experience on maintenance of Autoclave, GMP washer and other pharmaceutical operation equipment\'s.…
Department DetailsRole Summary1. Preparation, Execution & Compilation of PQ, RQ documents for Process Equipments as per cGMP compliance. 2. Revision of approved qualification (i.e., PQ/RQ/Study protocol & Report/Technical Document) document, whenever required. 3. Responsible to complete assigned activities as per…
Department DetailsRole Summary\xef\x81\xb6 Physically dispensing of raw materials & packing materials to production \xef\x81\xb6 Handling and monitoring of housekeeping activities \xef\x81\xb6 Handling of shop floor returned materials \xef\x81\xb6 Handling of Raw material/Packing material sampling and storage \xef\x81\xb6 Ensure online updation…
Department DetailsCQARole SummaryData Integrity Compliance OfficerKey ResponsibilitiesResponsibility 1. Ensure overall compliance to GxP requirements and data integrity point of view at site (Injectable and OSD). 2. Ensure the documentation practices followed at site as per cGMP and ALCOA+ principles. 3.…
Department DetailsRole Summary Implementation experience of SAP MDG in key domains such as Customer, Supplier, Material, Business Partners. Experience in Configuration rule based Workflow. Experience in Integrating business process requirements with the technical implementation of SAP Master Data Governance. Experience…
Department DetailsRole SummaryGlobal Program ManagementKey ResponsibilitiesJob profile: Program Manager R & D finance Department: Global Program Management R&D finance with 5 7 years of experience, the role typically involves a mix of financial analysis, budgeting, and strategic support for research…
Department DetailsRole Summary1. Candidate should have experience on maintenance of Automatic Vial washing Machine, Continuous sterilizer(Tunnel), Vial and Cartridge Filling machine and Sealing Machine. 2. Candidate should have experience on maintenance of Autoclave, GMP washer and other pharmaceutical operation equipment\'s.…
Department DetailsRole Summary1. Candidate should have experience on maintenance of Automatic Vial washing Machine, Continuous sterilizer(Tunnel), Vial and Cartridge Filling machine and Sealing Machine. 2. Candidate should have experience on maintenance of Autoclave, GMP washer and other pharmaceutical operation equipment\'s.…
Department DetailsRole Summary1. Candidate should have experience on maintenance of Automatic Vial washing Machine, Continuous sterilizer(Tunnel), Vial and Cartridge Filling machine and Sealing Machine. 2. Candidate should have experience on maintenance of Autoclave, GMP washer and other pharmaceutical operation equipment\'s.…
Department DetailsRole Summary1. Ensure quality oversight on all QMS documents and systems, to ensure consistency of global standards, harmonization, sharing of best practice and productivity. 3. Drive continuous improvement of the quality system to meet and sustain compliance with internal…
Department DetailsRole Summary1. Follow up area cleaning activity and perform cleaning of Mobile LAF and CMLs. 2. Preparation of buffers and filtration of buffers related to batch and updating of logbooks and log sheets. 3. Performing sampling activity during batch…
Department DetailsRole Summary Maintain inventory list of Scientific and QC applications at Site. Assist in 21 CFR Part 11 Assessment during Computerized system selection. Prepare and Maintain IT related SOPs (as applicable) for QC and Scientific automated systems. Perform/participated into…
Department DetailsRole Summary Analysis and Review of monthly payroll records and reporting financial information to management and government agencies Maintain Pay Register and oversee withholding tax related payroll processing Ensure that all compliances related to withholding tax, statutory liabilities etc…
Department DetailsRole Summary1. Follow up area cleaning activity and perform cleaning of Mobile LAF and CMLs. 2. Preparation of buffers and filtration of buffers related to batch and updating of logbooks and log sheets. 3. Performing sampling activity during batch…
Department DetailsRole Summary1. Follow up area cleaning activity and perform cleaning of Mobile LAF and CMLs. 2. Preparation of buffers and filtration of buffers related to batch and updating of logbooks and log sheets. 3. Performing sampling activity during batch…
Department DetailsRole Summary1. Follow up area cleaning activity and perform cleaning of Mobile LAF and CMLs. 2. Preparation of buffers and filtration of buffers related to batch and updating of logbooks and log sheets. 3. Performing sampling activity during batch…
Department DetailsRole Summary1. Follow up area cleaning activity and perform cleaning of Mobile LAF and CMLs. 2. Preparation of buffers and filtration of buffers related to batch and updating of logbooks and log sheets. 3. Performing sampling activity during batch…
Department DetailsRole Summary An incumbent engaged in the role of Senior Executive in CQA Quality Learning shall have: Not less than 06 years professional experience in a Health Agency auditable Function in the pharmaceutical industry. Prior knowledge and hands on…
Department DetailsRole Summary Assist in preparation for internal and external audits and inspections. Management (Communication and coordination) of regulatory/customer audits. Responsible to coordinate with CFTs in planning for readiness of Inspection, arrangement of documents, identifying the SMEs for discussion during…
Department DetailsRole Summary1. Provide quality oversight to upstream and downstream manufacturing activities like cell banking, inoculum preparation, 2kL production scale, chromatography operations & formulation of Drug Substance. 2. Responsible for upstream & downstream facility GMP compliance. 3. Responsible for shop…
Department DetailsRole SummaryGood understanding of downstream processing unit operations, process scale up is mandatory while knowledge of statistical domain will have added advantage Hands on experience downstream unit operations including chromatography, crystallization, lyophillization, filtration will be added advantage. The candidate…
Department DetailsRole Summary1. To ensure an effective global quality system is in place at B3 (Site 2), adequately resourced and the roles, responsibilities and authorities are defined, communicated, and implemented throughout the organization. 2. Should ensure effectiveness of the quality…
Department DetailsRole Summary1. Ensure quality oversight on all QMS documents and systems, to ensure consistency of global standards, harmonization, sharing of best practice and productivity. 3. Drive continuous improvement of the quality system to meet and sustain compliance with internal…
Department DetailsRole Summary1. Provide quality oversight to upstream and downstream manufacturing activities like cell banking, inoculum preparation, 2kL production scale, chromatography operations & formulation of Drug Substance. 2. Responsible for upstream & downstream facility GMP compliance. 3. Responsible for shop…
Department DetailsRole Summary1. Ensure quality oversight on all QMS documents and systems, to ensure consistency of global standards, harmonization, sharing of best practice and productivity. 3. Drive continuous improvement of the quality system to meet and sustain compliance with internal…
Department DetailsRole Summary Assist in preparation for internal and external audits and inspections. Management (Communication and coordination) of regulatory/customer audits. Responsible to coordinate with CFTs in planning for readiness of Inspection, arrangement of documents, identifying the SMEs for discussion during…
Department DetailsRole Summary1. To ensure an effective global quality system is in place at B3 (Site 2), adequately resourced and the roles, responsibilities and authorities are defined, communicated, and implemented throughout the organization. 2. Should ensure effectiveness of the quality…
Department DetailsRole SummaryMES IT System AdministratorKey Responsibilities Responsible for preparation of New Admin SOP\'s for any new manufacturing Systems. Responsible for performing PM, data backup, data restoration, data archival, Time Synchronization and user management activities described in the SOP\'s. Responsible…
Department DetailsRole Summary1. Develop Performance Dashboard, Score card & tracking matrix. 2. Responsible for collecting, processing, and interpreting the data from various sources 3. Creating meaningful reports and dashboards that provide insights and recommendations for the stakeholders. 4. Ensures the…
Department DetailsRole SummaryEngineering Maintenance and documentationKey Responsibilities Ensuring all accessories & auxiliary\'s operating conditions. Attending for general maintenance works as per complaint slip raised against particular equipment / system. Executing the day to day maintenance activities of production blocks. Execution…
Department DetailsRole Summary1. Establish, Implement and continual improve Occupational Health and safety, environment management practices for Treatment, Recycle and Disposal of solid, liquid wastes and gaseous emissions. 2. Establish, Implement and ensure safe working practices are followed throughout the companies…
Department DetailsRole SummaryAs a medical writer, s/he will be responsible for writing medico marketing content for articles, journals, brochures, product manuals and promo material for our organization. S/He will cover topics in specific therapy area, clinical trials, treatments, procedures, medical…
Department DetailsRole SummaryCommercial OperationsKey Responsibilities1. Coordinating with commercial leads in APAC for pending items to be followed up with internal CFTs at HO2. Coordinating with internal CFTs such as QA, QC, RA, Finance, Legal to ensure open action items of…
Department DetailsRole Summary1. Candidate should have experience on maintenance of Automatic Vial washing Machine, Continuous sterilizer(Tunnel), Vial and Cartridge Filling machine and Sealing Machine. 2. Candidate should have experience on maintenance of Autoclave, GMP washer and other pharmaceutical operation equipment\'s.…