247 Bmr Jobs

KPMG India is looking for Executive - Adobe QA to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

1. To study and understand the project quality and documentation requirements from the project brief with the help of the project design team. 2. To prepare the project and quality plan for all the ongoing projects. 3. To prepare the document list based on the project scope, project timeline, and quality plan, including internal and vendor-provided documents. 4. To inform all relevant departments about the documentation and quality requirements. 5. To collect, prepare, review, modify, and approve documents related to procurement, installation, commissioning, qualification, validation, and handover using standard tools and software. 6. To track all documents for availability, correctness, and approvals from the project team, concerned departments, and clients. 7. To prepare critical qualification and validation document requirement specifications (URS), validation master plan (VMP), project and quality plan, impact analysis, corrective action and preventive action (CAPA), standard operating procedures (SOPs), risk analysis, etc. 8. To prepare and update standard templates for design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), handover forms, installation protocols, commissioning protocols, etc. 9. To maintain the document history and change logs throughout the project life. 10.To verify the documents and drawings for numbering, formats, signature panels, approvals, etc. 11.To coordinate with the client for document approvals, maintain records, and confirm receipt and version control. 12.To follow up on all site activities documentation related to installation, commissioning, qualification, validation, and handover. To perform the site as required If needed, visit the. 13.To track and send protocols to the site as per testing and reporting needs. Supervisory Role: 1. To prepare a work plan and work hour list for all new projects within the heating, ventilation, and air conditioning (HVAC) department. 2. To regularly update the plan and work hour list and get the same approved by the project team and superiors. 3. To allocate workload to team members as per project needs and deadlines. 4. To coordinate with the project management department team on client queries and documentation timelines. 5. To review and approve the workload and deliverables of subordinates for accurate submission of documents required for purchases, client approvals, construction at sites, etc. 6. To ensure that all the department reports are updated on a timely basis. 7. To ensure that all the documents, internal and external, are accurately organized in the data management system (DMS) as per the project requirements and plan. Requirements Skills and Competencies: 1. Good understanding of the basic concepts of HVAC, clean room construction, clean room flooring, piping, utilities, production equipment, and electrical systems. 2. Fluent in written and spoken English and Hindi. 3. Self-motivated and target-oriented. 4. Capable of drafting SOPs and templates aligned with GMP and regulatory requirements. 5. Strong analytical and logical reasoning skills. 6. Competent with spreadsheets and document tracking tools. 7. Ability to perform under pressure and meet strict deadlines. 8. High accuracy in documentation and effective time management. Knowledge: 1. Knowledge of the pharmaceutical industry in general, dosage forms in the formulation industry, and various equipment and systems that go into the operation and construction of a facility. 2. Knowledge of the latest Food and Drug Administration (FDA) and international good manufacturing practice (GMP) documentation standards. 3. Good knowledge of qualification and validation documentation for a pharmaceutical facility. 4. Attending and representing the company in GMP audits, inspections by FDA agencies, and practical validation on the production floor would be an added advantage.

Pre-preparation for Customer Key Handover as per SOP. Generate rapport with the customers coming for Key Handover Demonstrate a high degree of warmth while dealing with / talking to the customers Register all customer feedback/concerns and channelize it as per SOP in order to close the loop. Maintain Customer data confidentiality. Any other activity associated with Customer Engagements/ Events - assist in these

As an intern at ThinQ Pharma, your day-to-day responsibilities will involve assisting in formulation and pre-formulation studies, supporting the development of stability and bio batches, helping in maintaining lab records including BMR/BPR and SOPs, coordinating with cross-functional teams such as QA/QC/Production, and performing basic lab tests while ensuring accurate data recording. ThinQ Pharma is an integrated pharmaceutical company with a strong global presence and a reputation for offering world-class products and services. Headquartered in Singapore and operating a fully equipped research center in Mumbai, India, ThinQ Pharma has been a key player in the global market for more than 25 years. With a highly skilled team, the company is committed to providing comprehensive solutions for the pharmaceutical and wellness industries.,

1.Perform and monitor In-process Quality Assurance activities during the manufacturing process. 2.Responsible to perform line clearance activities in different stages of manufacturing and Monitoring of cleanroom behavior, aseptic activities. 3.Responsible to verify the In-process samples for quality testing and ensure the test results of products at various stages of manufacturing. 4.Review and verify documentation related to manufacturing processes i.e., BMR, BPR and GMP documents, ensuring accuracy and completeness. 5.Regularly inspect and assess manufacturing operations to ensure compliance with quality standards and procedures. 6.Responsible to Preparation Review of standard operating procedures. 7.Responsible to ensure cGMP and GDP during document preparation and review. 8.Ensure that all in-process activities align with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP). 9.Responsible to review of Plasma inward, sampling procedures, Issuance and Reconciliation. 10.Responsible to Review and compliance of Down stream activities and Filling activities as per established procedures. 11.Responsible to involve in Change controls, Deviations, CAPA and other QMS activities. 12.To get involved in Process validation, cleaning validation and APQR activities. 13.To Involve in Risk assessment procedures with the coordination of SMEs. 14.Responsible to perform additional activities assigned by the superiors/ Head of the department.

1. Preparation of buffers and other solutions for plasma fractionation process. 2. Batch manufacturing record samples sending to QC for analysis. 3. Performing PHT, CIP and SIP of all the process vessels. 4.Follow shift schedule and production schedule, planning of shifts for the subordinate as per process requirement. 5. Preparation Review of equipment IQ, OQ and PQ documents. 6.To involve in Production planning and execution. 7. To get involved in technical discussion and planning for execution of new product validation batches and commercial batches in plant. 8. To get involved in Batch-to-batch yield analysis and investigation for low yield or OOS routed through Change control or deviation.

1.To involve in plasma products manufacturing. 2.Follow shift and production schedules. 3.To complete the assigned trainings timely. 4.To Monitor the differential pressure, temperature and humidity of the classified area. 5.To Ensure the area, equipments cleaning and readiness of equipments for batch activity. 6.Preparation of buffers and other solutions for downstream process. 7.Handling of process related instruments and equipments in downstream process (DSP). 8.Perform all the assigned manufacturing activities as per the defined procedures (SOP, BMR, Protocols) and record the details in respective document. 9.Checking the availability of stock of chemicals, solvents, raw material etc. 10.Coordinate with cross functional teams for smooth batch operations. 11.To maintain the facility to compliance with GMP. 12.Responsible for execution of relevant documents as per GDP. 13.To involve in equipment qualification and validation of the downstream equipments. 14.To involve in execution of process validation batches and regular manufacturing batches. 15.Provide samples to QC and take follow up for QC testing result. 16.In case of any abnormalities/ deviation observed should be recorded and informed to process in-charge to avoid any quality issues in the product. 17.To ensure adherence to safety procedure and report unsafe conditions and incidents to Supervisor. 18.To Involve in the preparation of SOPs and QMS documents. 19. To involve in new facility layout, equipment commissioning (URS, DQ, DS, FAT and SAT) documents preparation / review

1.To involve in plasma products manufacturing. 2.Follow shift and production schedules. 3.To complete the assigned trainings timely. 4.To Monitor the differential pressure, temperature and humidity of the classified area. 5.To Ensure the area, equipments cleaning and readiness of equipments for batch activity. 6.Preparation of buffers and other solutions for downstream process. 7.Handling of process related instruments and equipments in downstream process (DSP). 8.Perform all the assigned manufacturing activities as per the defined procedures (SOP, BMR, Protocols) and record the details in respective document. 9.Checking the availability of stock of chemicals, solvents, raw material etc. 10.Coordinate with cross functional teams for smooth batch operations. 11.To maintain the facility to compliance with GMP. 12.Responsible for execution of relevant documents as per GDP. 13.To involve in equipment qualification and validation of the downstream equipments. 14.To involve in execution of process validation batches and regular manufacturing batches. 15.Provide samples to QC and take follow up for QC testing result. 16.In case of any abnormalities/ deviation observed should be recorded and informed to process in-charge to avoid any quality issues in the product. 17.To ensure adherence to safety procedure and report unsafe conditions and incidents to Supervisor.

1. Follow shift schedule and production schedule as per process requirement. 2.Handling of plasma collection, sanitization, washing, cutting, pooling and thawing. 3.Handling of plasma fractionation process steps. 4.Compliance to all approved procedure, documents and GMP activities. 5.Performing all the assigned manufacturing activities in confirmation to BMR, protocols and recording the details in record sheets and logbooks. 6.In process samples sending to QC for analysis. 7.Performing COP, CIP, PHT and SIP of all the process vessels and equipment. 8.Performing calibration of pH, conductivity meters, turbidity meter, weighing balances and other equipment. 9.Preparation of buffers and other solutions for plasma fractionation process. 10.Monitoring of area cleaning, equipment surface sanitization, differential pressure, temperature and humidity 11.Monitoring and recording the temperature of freezer room and cold room. 12.To get involved in trouble shooting and managing day to day activities. 13.Checking the availability of stock of chemicals, solvents, raw material etc. 14.Report unsafe conditions and incidents to shift in-charge. 15.Adherence to safety procedures. 16.Awareness on PPE usage.

1. To perform the equipment sanitization and cleaning. 2. To perform and ensure area cleaning and sanitizationactivities. 3. To prepare and filter disinfectant solutions. 4. To perform the CIP, PHT and SIP of the process vessels. 5. To operate the machines and equipments like autoclave,lyophilizer, vial washing, vial filling and vial capping machine, vialpasteurizer and manufacturing vessels. 6. To perform the vial washing, filling and sealing machinechange parts assembling and dismantling according to different vial sizes. 7. To perform activities like machine parts cleaning, loadpreparation, load wrapping and garments washing. 8. Adhere to cGMP practices during batch processing andoperation of equipment and GDP practices. 9. All the GMP documents e.g., BMR and logbooks to be filledon time and revise periodically. 10. Adhere to aseptic batch processing and gowning practicesduring performing aseptic activities in DPM area. 11. To plan and ensure availability of machine and material asper the batch requirement. 12. To participate in Media fill, Trial batch and Validationbatch activities. 13. To involve in batch execution. 14. To support the batch manufacturing activities. 15. To perform and coordinate in site acceptance test,Installation qualification, Operational qualification and Performance qualificationsfor new equipments. 16. To maintain the Inventory consumable required for dailyactivities. 17. To coordinate with other cross functional team for smoothfunctioning of departmental activitie s.

1.Follow shift schedule and production schedule as per process requirement. 2.Handling of Fractionation process steps like plasma bags collection, sanitization washing, plasma cutting, pooling thawing. 3.Performing COP of all the vessels and equipments in plasma fractionation area. 4.Perform all the assigned manufacturing activities as per the defined procedures (SOP, BMR, Protocols) and record the details in respective document. 5.Sending the In-process samples to QC for analysis. 6.Materials should be collected from warehouse and QC. 7.Helping of plasma fractionation process steps. 8.Performing cleaning, calibration and operation of pH, conductivity meters, turbidity meter, weighing balances and other equipments. 9.Preparation of buffers and other solutions for plasma fractionation process. 10.Ensure the monitoring and performing of area cleaning, equipments surface sanitization, pressure differentials, temperature and relative humidity. 11.Process waste collection from clean rooms and the same should be sent to scrap yard. 12.Garments and shoes should be arranged into the respective change rooms. 13.Assembling and dis-assembling of centrifuge and filter press equipments. 14.To ensure adherence to safety procedure and report unsafe conditions and incidents to Supervisor.

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. 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. 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

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.

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. 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.

3-5 yrs of experience as CRC JD: Preparation of SOP's for operation, establishment of work/trial conduct systems/ training to new joiners/ training to trainers internal trainings, QC Visit of current project remotes, Checking weekly logs, equipment management, market Research

RoleKMIL - Monitoring Requirement2 Gender- Male/ Female both are preferred Education Background- CA / MBA (preference would be MBA- Finance) Experience level - 3 to 5 years (relevant experience not required) Preferred profile- Risk team of retail or wholesale division of any Bank / NBFC. The Key profile of Monitoring & Policy Risk Analyst is to carry out Risk Assessments for Pan India CRE Lending Portfolio is laid down below for your reference . Key responsibilities include Implement effective risk management processes for the Construction Finance business verticals to identify potential risk in the underwritten portfolio and ensure portfolio health Carry out background research and gain a thorough understanding on the project, the developer and the regional market, highlighting any negative reports so as to ensure the quality of the invested portfolio. Track the progress of the project and monitor disbursement as per the project lifecycle. Ensure that the disbursement milestones are achieved as per the underwritten sanctioned conditions. Recommend policy amendments/ refinements based on regulatory and market changes Undertake automation of existing processes by liaising with the IT department Prepare various dashboards and reports such as Monthly and quarterly portfolio monitoring report Overdue Analysis Early Warning Signals r eview Deviation Analysis Analytical Insights like Limit/ Renewal Management, Covenant/ PDD Management Trends analysis of the regional P ortfolio Perform various monitoring activities such as NOC issuance- Due diligence for the Monitoring and instruct for Escrow SI Threshold Map collections with the Escrow credits on regular intervals.

Job Title:- KMIL- Wholesale Banking- Risk Monitoring Analyst Grade:- M4/M5 Location:- Mumbai Track financial and project performance covenant: Monitoring financial and project performance against predefined convenants. Identify deviations and promptly communicate findings to relevant stakeholders. Project performance analysis: Conduct through analysis of project performance metrics. Provide insights and recommendations to mitigate risks. Track Compliances to sanctions conditions: Moniotor compliance with sanctions conditions imposed on credit facilities. Take proactive measures to address any non- compliance issue Site Visit: Conduct on site visit to assess the progress and status of projects. Documents observations and report findings to management Compliance with RERA regulations: Ensure adherence to regulatory guidelines and internal policies. Stay updated on regulatory changes and implement necessary adjustments. Early warning signal tracking: Identify early warning signal as per the existing policy indicating potential credit risks. Collaborate with relevant teams to develop strategies for risk mitigation. Coordination with business and credit underwriting team Liaise with business units and credit underwriting teams to gather relevant data and insights. Collaborate on credit risk assessment and monitoring activities. Job Requirement- MBA with 5 to 8 Years of experience is preferred

You will be responsible for issuing and receipting raw materials required for manufacturing Peptide Products. This includes charging batches and executing all activities related to the process in accordance with Batch Manufacturing Records (BMR) and documented procedures. Your role will involve the manufacturing of peptide products as per BMR and written procedures in the Peptide plant. Additionally, you will be in charge of operations, calibration, cleaning, and maintenance of process equipment. It will be essential to accurately record the usage logs of the equipment. Monitoring the process and cleaning turn around time (TR) during the synthesis and purification of Peptide products will also be part of your duties. You will play a crucial role in monitoring process parameters and yield to ensure efficiency. Your focus will be on reducing solvent usage, minimizing instrument downtime, and decreasing batch failures, hold-ups, and waste generation.,