2345 Data Validation Jobs - Page 23

1. Preparation, review and revision of SOPs, GTPs and Work sheets. 2. Execution of analytical method validation protocols for product samples. 3. Testing and review of product / Miscellaneous samples for AET. 4. Operation and maintenance of laboratory Instruments. 5. Monitoring of temperature, DP and RH of the Microbiology laboratory. 6. Involve in the execution of Media fill validations. 7. Cleaning, verification of laboratory cleaning and glassware cleaning in the Microbiology laboratory. 8. Receipt, storage, preparation, sterilization and maintenance of sterile media and reagents. 9. Performing the isolation, identification and confirmation tests for test organisms and Isolates. 10. Responsible for Growth promotion, inhibition test of Microbiological culture media. 11. Responsible for Biological indicator qualification, usage and testing. 12. Culture maintenance in Microbiology department. 13. Preparation and usage of disinfectants. 14. Review of outside COAs. 15. Review, checking and verification of all types Microbiology laboratory documents. 16. Responsible for implementation activities related to resource manager and sample manager of Laboratory information management System #40;LIMS#41;. 17. Verification of cleaning in the Microbiology laboratory. 18. Responsible for compliance to cGLP.

Planning and executing assay-runs for cell based assays and ELISA as part of Method Development and Method Qualification studies Analysis of the data using parallel line analysis and equivalence testing Writing protocols and reports for Method development and Method qualification studies Maintenance of the cell lines, preparation of cell banks Review of raw data and data recording sheets and to ensure good documentation practices. Planning of day-to-day activities independently. Trouble shooting of the issues (if any) aroused during execution of assay-run. Involving in documents preparation for SOP, STP, MOA.

1.Responsible for giving line clearance between startup of various finished product formulation and filling operations. 2.Responsible for performing in process checks during finished product operations as per respective established procedures. 3.Responsible for Monitoring and Coordination of process validation, Hold time studies, media fill and cleaning validation activities. 4. Responsible for preparation of IPQA SOPs and review of finished product SOPs. 5. Responsible for preparation of Annual Product Review Reports. 6. Responsible for continued process verification reports. 7.Responsible for compliance to GMP in finished product area. 8.Responsible for review of all finished product log books. 9.Responsible for review of master MFR and executed BFRs. 10.Responsible to attend training programs and SOP trainings. 11.Responsible for preparation of media fill BFR, protocol and report. 12.Responsible for monitoring of stability samples. 13.Responsible for preparation and review of visual inspection qualification protocol and report. 14.Day to Day Manufacturing observations Report to Manager QA.

1. Preparation and Maintenance of SOPs, STPs, Specifications, GTPs and Worksheets related to Product testing. 2. Preparation, revision, review and execution of Analytical method Validation protocols and reports related to product testing. 3. Responsibilities for preparation of masters (Product, Specifications, Tests, worksheets, Test plans and TTD etc.) in LIMS. 4. Responsibilities for effective documents (STPs, Specifications and GTPs etc.) uploaded in LDMS. 5. Responsible for material management like weekly, monthly indent Ensure monthly indents are placed and materials received in timely manner, reservation placed through SAP. Ensure compliance `w.r.t expiry, usage and discard of materials. 6. Operation and calibration of QC Instruments related to product testing. 7. 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 @ 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 Glycans by hydrophilic liquid interaction chromatography, etc.) 8. Preparation of reagent solutions, buffers and maintenance of the records. 9. Temperature and humidity monitoring of labs and instruments. 10. Sample receiving, A.R. No allotment, Testing, Documentation and reporting of analytical results in LIMS for In process, batch release, stability and Miscellaneous samples related to product testing. 11. Withdrawal and aliquoting of batch release and stability samples for analysis. 12. Responsible for preparation of shift schedules and test planning activities. 13. Responsible for cGLP compliance. 14. Responsible for handling of OOT (Out Of Trend), OOS (Out Of Specification), Incidents, LIRs and Change controls related to product testing. 15. Responsible for change management: Ensure CRNs initiation and closure within target date. 16. Preparation, revision and review of miscellaneous protocols and reports related to product testing. 17. Review of analytical data and work sheets related to product testing. 18. Maintenance of stability samples and reserve samples related to product testing. 19. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. 20. Responsible for usage, monitoring and verification of all kind of laboratory books. 21. Preparation, execution and review of reference standard qualification. 22. Maintenance of all QC documents related to product testing. 23. Assist in execution of Analytical method validations.

Specialized expertise in Inhaler Products including Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI). Method development, validation, and forced degradation studies specific to inhalation dosage forms. Execution and support of technology transfer for analytical methods related to MDI/DPI. Ensure compliance with Quality Assurance systems and applicable regulatory guidelines (ICH, FDA, EMA). Lead analytical activities for ANDA and NDA projects for respiratory products. Coordinate with cross-functional teams for project planning, documentation , and timely regulatory submissions. Review and preparation of analytical method validation protocols, reports, and supporting documentation for regulatory filings. Active involvement in OOS/OOT investigations, troubleshooting, and CAPA implementation.

Therapy expertise: Antidiabetics, preferably modern non-insulin antidiabeticdrugs like DPP4i, GLP1-RAs, SGLT2i etc. Key Responsibilities: 1. Brand Execution Market Adaptation Assist in implementing brand positioning and messaging for the Cardiac therapy portfolio, aligning with global guidelines. Conduct market research to understand therapy trends and competitive landscape. Adapt global marketing strategies for local markets while ensuring compliance and accuracy. 2. Promotional Campaign Development Support the creation of marketing collaterals such as brochures, flyers, digital assets, and promotional materials. Coordinate with creative teams to develop high-quality campaigns. Assist in executing HCP and patient communication strategies to drive awareness and adoption. 3. Business Region Support Training Work closely with regional marketing sales teams to support local execution of marketing plans. Assist in developing product training decks in collaboration with the medical team. Gather market insights and customer feedback to refine marketing approaches. 5. Cross-Functional Coordination Collaborate with Creative, Medical, and Regulatory teams to ensure seamless execution of marketing initiatives. Support new product launches and assist in lifecycle management activities. Align with regional and country-level teams to execute international marketing efforts effectively. 6. New Launch Responsibilities Support execution of launch campaigns, assist in sales team enablement,coordinate HCP engagement, adapt marketing materials gather marketfeedback for evolving Antidiabetic Therapies.

End-to-end formulation and development of injectable dosage forms (Liquid, Lyophilized, Emulsion, etc.) Handling of scale-up, exhibit batches, and tech transfer Cross-functional coordination with ADL, RA, QA, and Manufacturing

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

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.

Lead formulation and process development of HFA-based MDI products for regulated markets (US, EU, etc.). Manage drug-device combination product development , including coordination with device vendors for CMC and regulatory compliance. Coordinate cross-functionally with analytical, regulatory, clinical, and manufacturing teams to ensure timely project execution. Drive process optimization at the lab scale using QbD principles; establish control strategies for successful scale-up. Design and define product specifications in compliance with current global regulatory guidelines. Review Product Development Reports, Technology Transfer Reports , and Deviation/Investigation Reports for technical accuracy. Support regulatory query responses related to product development and manufacturing in collaboration with relevant departments. Lead technology transfer of HFA-based MDIs to contract manufacturing organizations (CMOs) for domestic and international markets. Provide technical and regulatory support for submissions including NDA, ANDA, and 505(b)(2) applications. Troubleshoot formulation-related issues during manufacturing to ensure smooth and compliant commercial production.

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.

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.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.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. 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. 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.

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.

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.