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0.0 - 7.0 years
2 - 6 Lacs
Hyderabad
Work from Office
1) Preparationof Analytical method validation Protocols and reports for the relatedsubstances and Assay by HPLC and residual solvents by GC 2) Preparation of Analytical methodvalidation Protocols and reports for the Identification analysis by HPLC,GC andparticle size analyzer and performing the analytical method validations for theIdentification, content and purity analysis by HPLC,GC and Particle sizeanalyzer. 3) Performing the Analytical methodvalidations by HPLC and GC. 4) R esponsible to follow and ensure strict compliance to GLP practices in the laboratory to meet the organizational goal which in line with procedural references. 5) Maintenance of log books and Calibration records as per procedural references. 6) Preparation of Analytical method validation Protocols and report for the Elemental Impurities analysis by ICP-MS and Perform the analytical method validations for elemental impurities by ICP-MS.
Posted 3 days ago
0.0 - 5.0 years
1 - 5 Lacs
Hyderabad, Jadcherla
Work from Office
1. Aseptic handling. 2. Media and feeds preparation for shake flasks experiment and bioreactors batches. 3. Shake flasks handling for clone, media and feed selection. 4. Bioreactors preparation (1L,5L,20L). 5. Batch execution in small scale bioreactors and large-scale bioreactors. 6. In process sample analysis like cell count, viability, metabolites (glucose, lactate, ammonia, glutamine etc. 7. SOP preparation related to instruments and process. 8. Shift duties for batch monitoring. 9. Able to work in a team.
Posted 3 days ago
0.0 - 3.0 years
1 - 5 Lacs
Hyderabad
Work from Office
The Junior Analyst/Executive in Analytical Research and Development (ARD) Injectables plays a vital support role in the development and evaluation of sterile pharmaceutical products This position involves performing routine analytical testing of injectable dosage forms such as solutions, lyophilized powders, emulsions, and suspensions using instruments like HPLC, UV-Vis, FTIR, pH meter, and more Under the guidance of senior scientists, the junior analyst assists in method development, validation, and stability studies, ensuring that data is accurate and meets regulatory and internal quality standards Responsibilities include sample preparation, instrument handling, maintaining laboratory notebooks, and following Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) The role also includes preparing reagents, calibrating instruments, and maintaining documentation for analytical procedures and observations Junior analysts support data compilation for regulatory submissions and assist in investigations related to analytical deviations or out-of-specification results They collaborate with cross-functional teams such as Formulation RD, QA, and Regulatory Affairs to ensure timely and compliant development activities This position requires attention to detail, a willingness to learn, and the ability to follow procedures precisely Ideal candidates should hold a Pharm, MPharm (Pharmaceutical Analysis or Pharmaceutics
Posted 3 days ago
0.0 - 2.0 years
1 - 5 Lacs
Hyderabad, Jadcherla
Work from Office
The candidate would be developing various analytical method (such as CD, Fluorescence spectrscopy ,CE UH/HPLC etc..)for CQA to support biosimilarity and analytical studies. Qualify method for biosimilarity and analytical studies. Responsible for performing biosimilarity, characterization and analytical studies for various molecules across lifecycle . Evaluation, interpretation and graphical representation of the measurement data as well as presentation of the results obtained from multiple experiments. Author technical documents such as MoA,MQR,SOP,study protocol and report.
Posted 3 days ago
2.0 - 5.0 years
2 - 6 Lacs
Hyderabad
Work from Office
Development and validation of analytical methods for injectable dosage forms Stability study execution and data interpretation Support for formulation development and regulatory submissions (US/EU) Instrument handling: HPLC, GC, UV, KF, etc. Preparation of method validation reports, protocols, and SOPs
Posted 3 days ago
1.0 - 3.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
1. Responsible for operation and cleaning of PFS/Vial filling stoppering and Sealing machine. 2. Responsible for operation and cleaning of Lyophilizer machine. 3. Responsible for involvement in aseptic media fills formulation and filling activities in aseptic areas. 4. Responsible for operation and cleaning of HPHV steam sterilizer. 5. Responsible for cleaning, preparation of machine parts and loads as per load pattern. 6. Preparation and filtration of disinfectants, IPA etc., 7. Responsible for area and equipments cleaning in FP facility. 8. Handling of APA equipments and to be involved in personnel gowning qualification. 9. Online Execution of Batch documents and related logbooks. 10. Handling of various types of filters and filter integrities. 11. Execution of preventive maintenance plan for equipments in coordination with engineering. 12. Maintaining of day to day activities in manufacturing areas. 13. Performing DQ, IQ, OQ, and PQ for the equipments in aseptic processing area and other associated areas.
Posted 3 days ago
2.0 - 4.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for operation and handling of Dataloggers, HVAC related equipments. 5. Responsible for compilation and review of validation raw data and test certificates. 6. Responsible for preparation of Installation qualification (IQ), Operational qualification (OQ) and Performance qualification (PQ), revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records. 9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities. 10. Responsible for handling of risk assessments, deviation, change control and incidents related to qualification/validation. 11. Responsible for preparation of Utilities Annual summary reports.
Posted 3 days ago
3.0 - 4.0 years
1 - 4 Lacs
Hyderabad
Work from Office
Sterilization and preparation of media, Media growth promotion test, Media fill validations. Analysis of Pathogenesis test, MET, Environmental monitoring. Hands on experience in Analyzing of ELISA techniques like Binding ELISAs, Impurity based Assays HCP, LPA. Analysis of electrophoresis methods such as SDS-PAGE, IEF. Analysis of In-Process, DS, DP and Stability samples. Exractable volume of final DP sample. Aliquoting of batch release, stability samples. Withdrawing of stability samples as per the protocol. Receiving, storage and Physical verification of Reserve samples
Posted 3 days ago
1.0 - 4.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
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;
Posted 3 days ago
3.0 - 5.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
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
Posted 3 days ago
3.0 - 6.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
1. Responsible for operation and cleaning of PFS/Vial filling stoppering and Sealing machine. 2. Responsible for operation and cleaning of Lyophilizer machine. 3. Responsible for involvement in aseptic media fills formulation and filling activities in aseptic areas. 4. Responsible for operation and cleaning of HPHV steam sterilizer. 5. Responsible for cleaning, preparation of machine parts and loads as per load pattern. 6. Preparation and filtration of disinfectants, IPA etc., 7. Responsible for area and equipments cleaning in FP facility. 8. Handling of APA equipments and to be involved in personnel gowning qualification. 9. Online Execution of Batch documents and related logbooks. 10. Handling of various types of filters and filter integrities. 11. Execution of preventive maintenance plan for equipments in coordination with engineering. 12. Maintaining of day to day activities in manufacturing areas. 13. Performing DQ, IQ, OQ, and PQ for the equipments in aseptic processing area and other associated areas.
Posted 3 days ago
1.0 - 4.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
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.
Posted 3 days ago
0.0 - 3.0 years
1 - 3 Lacs
Hyderabad, Jadcherla
Work from Office
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).
Posted 3 days ago
0.0 - 1.0 years
1 - 3 Lacs
Hyderabad, Jadcherla
Work from Office
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
Posted 3 days ago
1.0 - 3.0 years
1 - 3 Lacs
Hyderabad, Jadcherla
Work from Office
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
Posted 3 days ago
0.0 - 2.0 years
1 - 3 Lacs
Hyderabad, Jadcherla
Work from Office
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.
Posted 3 days ago
3.0 - 6.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
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.
Posted 3 days ago
0.0 - 1.0 years
1 - 3 Lacs
Hyderabad, Jadcherla
Work from Office
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;
Posted 3 days ago
0.0 - 1.0 years
1 - 3 Lacs
Hyderabad, Jadcherla
Work from Office
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
Posted 3 days ago
1.0 - 5.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
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.
Posted 3 days ago
3.0 - 5.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
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.
Posted 3 days ago
3.0 - 6.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
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
Posted 3 days ago
3.0 - 6.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
1. Execution of production plan for formulation and filling. 2. Achieving planned FP targets with strict adherence to cGMP. 3. Execution of planned activities of Aseptic Processing Areas like media fills simulation trails, Formulation and filling activities. 4. Ensuring of sterilizing loads, cleanliness of filling room, entry and exit change rooms of aseptic areas. 5. Preparing and implementation of standard operating Procedures, Protocols, cleaning procedures and relevant log sheets. 6. On-line execution of Batch documents and related logbooks. 7. Execution of preventive maintenance plan for equipments in coordination with Engineering and QA departments. 8. Maintaining documents as per regulatory and cGMP norms. 9. Performing day to day activities in manufacturing areas. 10. Reporting all the activities, incidents and issues to Reporting Manager. 11. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 12. Handling of SAP and DMS as per the requirement.
Posted 3 days ago
0.0 - 1.0 years
4 - 8 Lacs
Lucknow
Work from Office
Eligibility : M.Sc / M.tech (Life Sciences / Biotechnology) Technical Skills : Various Extraction Techniques Purification techniques Phytochemical Activity (Qualitative quantitative) HPLC CG AAS FTIR UV-Vis Spectrophotometer General Skills : Complete knowledge of MS Office Standardisation of SOP Sample flow management English (Reading and Writing) Candidate must have a personal Laptop
Posted 3 days ago
0.0 - 1.0 years
6 - 9 Lacs
Lucknow
Work from Office
Eligibility : M.Sc / M.tech (Life Sciences / Biotechnology) Technical Skills : Proximate Analysis Adulteration Test Microbial Count Antioxidant Activity Micronutrient detection General Skills : Complete knowledge of MS Office Standardisation of SOP Sample flow management English (Reading and Writing) Candidate must have a personal Laptop
Posted 3 days ago
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