1756 Gmp Jobs - Page 15

Design and execute experiments related to the formulation development of oral solid dosage forms using HME techniques. Operate and maintain HME equipment including twin-screw extruders, feeders, and associated downstream processing units (milling, compaction, etc.). Conduct pre-formulation studies, including excipient compatibility and thermal analysis (DSC, TGA). Perform process optimization and scale-up studies for HME-based formulations. Prepare solid dispersions, amorphous systems, and evaluate physical and chemical stability. Perform solid-state characterization using tools such as XRPD, FTIR, Raman spectroscopy, and microscopy.

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

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.

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.

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

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. 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.

1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Monitoring of area drains cleaning and documents updation. Updation of area / equipment status labels. Samples handling (Sampling and labelling). Arrangement of material required for activities. Assisting in Execution of production activities. Updation of BMR's. Receiving material (RM miscellaneous). Returning miscellaneous materials to warehouse. Planning and Execution of FDS thawing and dispensing activities. Assisting in product changeover activities before batch execution. Assisting column packing and execution of equipment specific protocols. Assisting in Equipment (Purification TFF system) cleaning.

Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia , including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines . Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions . Manage regulatory responses to queries and deficiency letters from health authorities and clients , ensuring resolution within timelines. Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation. Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions. Prepare regulatory documents for GMP inspections , tender submissions , and related regulatory filings. Stay updated with regional regulatory developments , including changes in biopharmaceutical regulations and evolving health authority expectations. Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements. Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines. Support the development of regulatory strategies for new product launches and geographic expansion within Asia. Ensure compliance with global and local regulatorySOPs and documentation standards .

Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines. Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions. Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timelines. Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation. Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions. Prepare regulatory documents for GMP inspections, tender submissions, and related regulatory filings. Stay updated with regional regulatory developments, including changes in biopharmaceutical regulations and evolving health authority expectations. Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements. Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines. Support the development of regulatory strategies for new product launches and geographic expansion within Asia. Ensure compliance with global and local regulatory SOPs and documentation standards.

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

We are looking for a skilled MySQL DBA Professional with 5-10 years of experience to join our team in IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in database administration and management. Roles and Responsibility Design, implement, and manage database architectures to support business requirements. Develop and maintain databases to ensure high performance, security, and availability. Collaborate with cross-functional teams to identify and prioritize database needs. Troubleshoot and resolve complex database issues efficiently. Ensure compliance with organizational standards and best practices. Optimize database queries for improved performance and efficiency. Job Requirements Strong knowledge of MySQL database administration and management. Experience with database design, development, and implementation. Excellent problem-solving skills and attention to detail. Ability to work collaboratively in a team environment. Strong communication and interpersonal skills. Familiarity with database security and access control measures. Proficiency in managing large-scale databases and ensuring data integrity.

We are looking for a skilled Kneat CSV Professional with 6-12 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in Recruitment / Staffing and excellent skills in Kneat CSV. Roles and Responsibility Manage and implement Kneat CSV solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain technical documentation for Kneat CSV projects. Provide training and support to clients on Kneat CSV tools and features. Troubleshoot and resolve issues related to Kneat CSV implementation. Analyze and optimize client data processing workflows using Kneat CSV. Job Requirements Strong knowledge of Kneat CSV principles and practices. Experience working with large datasets and complex data processing systems. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong problem-solving and analytical skills. Familiarity with industry-standard data integration tools and technologies.

Roles and Responsibilities Operate formulation machines such as FBC, blender, coating, and dryers. Ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practice (GDP). Monitor machine performance and troubleshoot issues to minimize downtime. Maintain accurate records of production runs and quality control tests. Collaborate with team members to achieve production targets. Desired Candidate Profile 2-6 years of experience in pharmaceutical manufacturing operations or related field. Strong understanding of GMP/GDP regulations and industry standards. Proficiency in operating various types of machinery including dryers, mills, etc.