115 Jobs in Jadcherla - Page 2

1. To perform Equipment operation and cleaning. 2. To supervise the Visual inspection and batch packing execution as per plan. 3. To perform the documentation as per Batch record and SOP. 4. To perform the equipment qualification as per protocols and SOP. 5. Responsible to maintain documents as per cGMP norms. 6. Co-ordinate to cross functional team as per day-to-day activities. 7. Responsible for SOP, MPR and BPR preparation and revision. 8. Co-ordination with team to execute daily packing and visual inspection plan. 9. Ensure the training completion before doing activity. 10. To raise batch record request as per plan. 11. Responsible for QMS related activity(Change control, Deviations, Batch record) in packing and visual inspection activity. 12. Monitor day to day activities. 13. Reporting all the activities, incidents and problems to Reporting officer

01. Responsible for daily verification and calibration of weighing balances. 02. Dispensing of all materials. 03. Responsible for updating of records for temperature, relative humidity and differential Pressure. 04. Responsible for preparation of disinfectant solution and record updation. 05. Responsible for cleaning activities in warehouse. 06. Responsible for operation and cleaning of walk in cold room, deep freezer, dispensing booth and sampling booth as per the procedure. 07. Responsible for cleaning of dispensing area / dispensing aids after completion of activity. 08. Responsible for updation of cleaning and dispensing log books. 09. Responsible for receipt of materials 10. Responsible for GRN preparation in SAP. 11. Responsible for stock verification periodically in warehouse

1. Responsible for operation and cleaning of Vial washing machine and Depyrogenating tunnel. 2. Responsible for involvement in aseptic media fills formulation and filling activities in aseptic areas. 3. Responsible for operation and cleaning of HPHV Steam sterilizer. 4. Responsible for cleaning, preparation of components as per load pattern. 5. Preparation and filtration of disinfectants, IPA etc., 6. Responsible for area and equipments cleaning in FP facility. 7. Handling of APA equipments and to be involved in personnel gowning qualification. 8. Online Execution of Batch documents and related logbooks. 9. Handling of various types of filters and filter integrities. 10. Execution of preventive maintenance plan for equipments in coordination with engineering. 11. Maintaining of day to day activities in manufacturing areas. 12. Performing DQ, IQ, OQ, and PQ for the equipments in aseptic processing area and other associated areas. 13. Reporting all the activities like incidents and problems to reporting officer 14. independent handling of Formulation and filtration activities.

Develop the die lines/KLDs and coordinate with the vendors for new launch products on secondary and tertiary packing materials. Coordinate with vendors, PPIC, and Warehouse for material procurement. Coordinate with cross-functional teams and conduct trials for secondary packing materials Monitor day-to-day activities. Inputs on artwork design to meet marketing requirements for secondary and tertiary packaging materials. Review and approve the specifications of secondary and tertiary packaging materials for QC. Coordinate with cross-functional teams and customers for artwork preparation and approval. Review and approval of print proofs and shade cards. Review of Pack profiles. Responsible for QMS-related activities in Packaging Development. Perform documentation as per SOP Responsible for maintaining documents in compliance with cGMP norms. Responsible for the Change control and incident reporting. Responsible for pack configuration finalization. Responsible for the completion of dangerous goods (DG) and general product transport validation studies. Responsible for the implementation of functionality studies of primary packaging material Responsible for the implementation of barcode system on packaging material. Implementation of Track and Trace system for export markets Evaluation of RLD/Reference product packaging material. Development of new change parts. Provide training to team members. Ensure document compliance with regulatory requirements. Report all activities and issues to the Reporting Officer. Timely Ensuring the availability of Materials for batch manufacturing activities.

1.Preparation, revision and review of SOPs, STPs, Specifications and GTPs and Worksheets related to product testing for electrophoresis lab 2.Preparation, revision and review of analytical method Validation protocols and reports related to product testing. 3.Responsible for shift schedules and test planning activities. 4.Testing, documentation, review and release of In-process, Batch release, Stability and Miscellaneous samples. 5.Responsible for handling of OOS, OOT, Incidents, LIRs, Change controls, Deviations and Risk Assessments. 6.Preparation, revision and review of miscellaneous protocols and reports related to product testing. 7.Responsible for training of QC analysts and new joiners related to product testing. 8.Maintenance of all QC documents related to product testing. 9.Responsible for GLP compliance. 10.Responsible for calibrations, validations and PMP of instruments related to product testing. 11.Responsible for conducting internal audit of other departments as part of GMP compliance. 12.Responsible for general cleanliness of laboratory 13.Responsible for preparation for URS. 14.Responsible for Coordinating with inter and intra departments for technical discussions. 15.Responsible for samples sending and checking of outside laboratory reports. 16.Responsible for preparation and uploading of job responsibilities for new joinee or whenever employee job role change. 17.Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications.

1. Environmental monitoring in manufacturing facilities, Warehouse facilities, Microbiology laboratory and Bioassay area. 2. Instruments calibrations, validation / revalidation, operation and usage. 3. Preparation and sterilization of microbiological media, reagents and materials 4. Sampling and analysis of compressed gases and Drain monitoring in manufacturing facilities. 5. Documentation of the media consumption records and review of outside COAs. 6. Preparation of disinfectants and Swab analysis. 7. Involve in the execution of Media fill validations. 8. Performing area qualification and requalification of Manufacturing facilities, Warehouse facilities, Microbiology laboratory and Bioassay area. 9. Performing gowning qualification and requalification of Manufacturing facilities and Microbiology laboratory. 10. Performing environmental monitoring and nonviable particle count of manufacturing facilities, Warehouse facilities, Microbiology laboratory and Bioassay area. 11. Responsible for compliance to cGLP.

Responsible for production activities Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room Training: Attending training on SOP's / GMP as per schedule.

1. Operation and maintenance of Instruments. 2. Receipt, storage and usage of microbiological dehydrated media and other microbiology laboratory consumables. 3. Reconciliation and maintenance of sterile media. 4. Preparation of dilute disinfectants, cleaning, reagents solutions / indicator solutions. 5. Responsible for handling of Bio-waste in Microbiology department. 6. Monitoring of temperature, DP and RH of the Microbiology laboratory. 7. Preparation, sterilization and maintenance of sterile media and reagents. 8. Review, checking and verification of all types Microbiology laboratory documents. 9. Verification of cleaning in the Microbiology laboratory. 10. Responsible for compliance to cGLP. 11. Performing the isolation, identification and confirmation tests for test organisms and Isolates. 12. Responsible for Growth promotion, inhibition test of Microbiological culture media. 13. Responsible for Biological indicator qualification, usage and testing. 14. Culture maintenance in Microbiology department. 15. Preparation and usage of disinfectants. 16. Any job allotted by Department head.

1. To perform Area cleaning. 2. To perform Equipment operation and cleaning. 3. To perform the visual inspection and packing activities. 4. To perform the documentation as per Batch record and SOP. 5. Responsible to maintain documents as per cGMP norms. 6. Ensure the training completion before doing activity. 7. Maintain personal hygiene. 8. Reporting all the activities, incidents and problems to Reporting officer.

1.Responsible for preparation of training related SOPs. 2. Responsible for preparation of induction training schedule for newly joined employees. 3. Evaluation of induction training programme of newly joined personnel. 4. Responsible for collection of specimen signatures of all newly joined employees. 5. Coordination with concerned department head, for preparation of job responsibilities. 6. Responsible for review evaluation of newly joined personnel on the job training schedule. 7. Responsible for activation, modification/deactivation of electronic access control in the facility. 8. Responsible for preparation GMPSafety training schedules. 9. Training requirements identification in coordination with concerned departments. 10. Responsible to attend the training programs. 11. Coordination for conducting trainings on SOPs and GMP trainings. 12.Responsible for LIMS and TRIMS administration activities. 13.Responsible for handling of CRNs, Incidents and CAPAs. 14.Responsible for the Custody, Issue Control of all master documents (SOPs and Specification, STPs, Protocols and Batch Records).

1. To perform Equipment operation and cleaning. 2. To supervise the Visual inspection and batch packing execution as per plan. 3. To perform the documentation as per Batch record and SOP. 4. To perform the equipment qualification as per protocols and SOP. 5. Responsible to maintain documents as per cGMP norms. 6. Co-ordinate to cross functional team as per day-to-day activities. 7. Responsible for SOP, MPR and BPR preparation and revision. 8. Co-ordination with team to execute daily packing and visual inspection plan. 9. Ensure the training completion before doing activity. 10. To raise batch record request as per plan. 11. Responsible for QMS related activity (Change control, Deviations, Batch record) in packing and visual inspection activity. 12. Monitor day to day activities. 13. Reporting all the activities, incidents and problems to Reporting officer.

1. Follow SOPs, GMP and safety practices. 2. Facility Area cleaning, Equipment cleaning, drains cleaning sanitization. 70 % IPA arrangement. Discarding general waste, rejects and biowaste. Log books updation. Spillage management. Updating of BMRs and annexures online. 3. Material Arrangement of plastic / glassware. Material packing for sterilization. Arrangement of garments. Arrangement of materials. 4. Process Arrangement of drums and installation of bags. Collection of WFI. Movement of prepared media/buffer to process rooms. Assisting in cleaning of equipments. Movement of samples. Execution of production activities. Monitoring of batch parameters. Arrangement of HDPE Drums, Vessels and installation of SUM bags and liner bags. Samples handling (Sampling and labelling). Handling of Depth filters assembly and harvest activities. Media Buffer preparation activities for process. LN2 container handling for filling activities. 5. Participate in training programs as per training schedule. 6. Responsible for operation of following production equipments (but not limited to): Mixing systems Weighing balance Magnetic stirrer Peristaltic pumps pH meter Cold Room Freezer Heat exchanger Depth filter holders Laminar air flow cabinet Biosafety cabinet Pass box LN2 container

Operation and calibration of QC Instruments related to product testing. Testing and release of product samples by techniques such as: General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.) Gel Electrophoresis (IEF, SDS-PAGE, etc.) Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.) Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD at 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.) ELISAs (Host Cell derived Proteins, Protein A Leachate, etc.) Q-PCR (Host Cell DNA, Mycoplasma testing etc.) HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.) UPLC techniques (Cation exchange chromatography, Protein A Chromatography, N-Linked Glycan by hydrophilic liquid interaction chromatography, Peptide mapping, Size exclusion chromatography etc.) Capillary electrophoresis. Temperature and humidity monitoring of labs and instruments. Responsible for cGLP compliance. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. Responsible for usage, monitoring and verification of all kinds of laboratory books. Assist in execution of Analytical method validations

1. Responsible for operation and cleaning of HPHV steam sterilizer 2. Responsible for operation and cleaning of vial washing machine and depyrogenation tunnel. 3. Responsible for preparation of machine parts and load patterns. 4. Responsible for Washing and preparation of garments for manufacturing areas. 5. Preparation and filtration of disinfectants, IPA etc. 6. Cleaning of equipments and rooms in processing areas. 7. Online Execution of Batch documents and related logbooks. 8. Handling of various type of filters and filter integrities. 9. Participate in qualification of equipments (DQ, IQ, OQ and PQ) in manufacturing areas. 10. Execution of production related activities and achieving planned FP targets with cGMP. 11. Following of cleaning procedures and entering data in the relevant log books. 12. Maintaining of day-to-day activities in manufacturing areas. 13. Reporting all the activities, deviations and problems to reporting officer. 14. Follow the regular training programmers for individuals in respective area

Responsible for production (downstream) activities Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. Chromatography column and resin monitoring. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room Training: Attending training on SOP's / GMP as per schedule.

1. Receipt, storage and usage of medias, Microbial cultures, materials and documentation 2. Perform viable / non-viable monitoring activities, media plates observations and documentation in testing facilities. 3. Environmental monitoring, sampling, receipt, testing and documentation of all Microbiology samples. 4. Perform cleaning, fumigation and other activities in Microbiology laboratory. 5. Monitoring of temperature, DP and RH of the Microbiology laboratory. 6. Preparation of dilute disinfectants, reagents solutions / indicator solutions. 7. Responsible for compliance to cGLP. 8. Operation and usage of instruments. 9. Execution of method validations / method verification samples. 10. Receipt / testing of validation samples from manufacturing / other areas 11. Training and qualification of analysts in Microbiology department. 12. Responsible for handling of Bio-waste in Microbiology department. 13. Review, checking and verification Microbiology laboratory documents. 14. Responsible for implementation activities related to resource manager and sample manager of Laboratory information management System #40;LIMS#41;

1. Perform cleaning, fumigation and other activities in Microbiology laboratory. 2. Monitoring of temperature, DP and RH of the Microbiology laboratory. 3. Preparation of dilute disinfectants, reagents solutions / indicator solutions. 4. Operation and maintenance of Instruments. 5. Responsible for packing of materials, sterilization and depyrogenation. 6. Responsible for handling of Bio-waste in Quality control and Microbiology laboratory. 7. Collection of Purified water and Water for injection for laboratory usage. 8. Transfer of materials from warehouse to Quality control Department. 9. Transfer of Monitoring and sampling kits within Blocks. 10. Receipt and Analytical Reference Number generation for water / miscellaneous samples. 11. Responsible for compliance to cGLP.

01. Responsible for daily verification and calibration of weighing balances. 02. Dispensing of all materials. 03. Responsible for updating of records for temperature, relative humidity and differential Pressure. 04. Responsible for preparation of disinfectant solution and record updation. 05. Responsible for cleaning activities in warehouse. 06. Responsible for operation and cleaning of walk in cold room, deep freezer, dispensing booth and sampling booth as per the procedure. 07. Responsible for cleaning of dispensing area / dispensing aids after completion of activity. 08. Responsible for updation of cleaning and dispensing log books.

1. Following GMP, safety practices in production facilities and work place. 2. Responsible for buffer preparation activities Area drains cleaning and documents updation. Verification and receiving of material required for buffer preparation activities. Execution of Buffer preparation activities. Preparation of area, equipments before batch activities. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Updation of room / equipment status labels. Arrangement of sterile material. 3. Handling of documents Updation of log books. Updation of BMRs and protocols/reports 4. Responsible for operation of following production equipments Mixing systems Conductivity meter Weighing balance Peristaltic pumps Walk in Cold room Freezer room Magnetic Stirrer pH meter Heat exchanger 5. Attending training on SOP's / GMP as per schedule

Responsible for production activities 1. Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. 2. Chromatography column and resin monitoring. 3. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. 4. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room 5. Training: Attending training on SOP's / GMP as per schedule. 6. Responsible for Quality Management Systems Initiation of breakdown request. Initiation of CRN's. Initiation of incidents, Investigations and CAPA.Please enter job description

1. Responsible for preparation of training related SOPs. 2. Responsible for preparation of induction training schedule for newly joined employees. 3. Evaluation of induction training programme of newly joined personnel. 4. Responsible for collection of specimen signatures of all newly joined employees. 5. Coordination with concerned department head, for preparation of job responsibilities. 6. Responsible for review evaluation of newly joined personnel on the job training schedule. 7. Responsible for activation, modification/deactivation of electronic access control in the facility. 8. Responsible for preparation GMPSafety training schedules. 9. Training requirements identification in coordination with concerned departments. 10. Responsible to attend the training programs. 11. Coordination for conducting trainings on SOPs and GMP trainings. 12. Responsible for LIMS and TRIMS administration activities. 13. Responsible for handling of CRNs, Incidents and CAPAs. 14. Responsible for the Custody, Issue Control of all master documents (SOPs, Specifications, STPs, Protocols and Batch Records). 15. Responsible for Control, Issue and Retrieval of the Formats and Registers. 16. Responsible for Storage, Retrieval, Control Retention of all Completed documents (including software). 17. Responsible for issuance and reconciliation of Batch record documents. 18. Responsible for the Custody, Issue Control of Work Sheet for Record of Analysis. 19. Responsible for compliance to GMP. 20. Responsible for Allotment of batch numbers.

Lead QA oversight for RD, analytical process development, and tech transfer. Ensure compliance with GMP, GLP, ICH, and global regulatory standards. Review and approve development protocols, validation reports, and CMC docs. Handle deviations, CAPAs, change controls, and data integrity (ALCOA+). Support audits, inspections, and regulatory filings (IND, BLA, DMF). Mentor and manage QA team, and drive quality culture across development.

To Plan Monitor work force in labelling packing. To ensure business orders are executed on time as per customer requirement. To ensue SAP compliance. To Plan Monitor work force in Visual inspection. To ensure visual inspectors are in qualified state. To ensure all drug products movement in Cold room with safe systematic approach. To identify/perform/review QMS related activities in Packing and visual inspection. To ensure all quality systems are in place before product process activity. To handle regulatory and non-regulatory audits as lead Role. To plan Trainings, improvements, Stress management, Feedback Mechanism ,Skill test ,Outing etc. for Team members. To identify/evaluate/Implement the exact requirement with respect to equipment/Manpower/new method/Safety by forecasting approach. Report to Reporting manager related to daily work/any hurdles.

1. Responsible for operation and maintenance of the chiller, pumps, cooling towers as per operating procedures. 2. Responsible for operation and maintenance of air compressors as per operating procedure. 3. Responsible for operation and maintenance of gas handling (O2, N2 CO2) system as per operating procedure. 4. Responsible for operation and maintenance of Kill tank. 5. Responsible for operation and maintenance of Decontamination Autoclaves. 6. Responsible to raise the work permits for all types of engineering works. 7. Coordination with all departments personnel for day to day activities. 8. Responsible for identifying and indenting of critical spares (if necessary) intimate the same to reporting authority. 9. In case of absence, the person who has trained in similar jobs is responsible for all the above activities.

1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance of GLP in Lab. 10. Responsible for review and approval of LIMS related activities. 11. Approval and issuance of configured COA in LIMS. 12. Responsible for audit trail verification for QC lab instruments.