974 Sop Jobs - Page 9

Voltech Engineers Global is looking for Senior Testing Commissioning Engineer to join our dynamic team and embark on a rewarding career journey Analyzing customer needs to determine appropriate solutions for complex technical issues Creating technical diagrams, flowcharts, formulas, and other written documentation to support projects Providing guidance to junior engineers on projects within their areas of expertise Conducting research on new technologies and products in order to recommend improvements to current processes Developing designs for new products or systems based on customer specifications Researching existing technologies to determine how they could be applied in new ways to solve problems Reviewing existing products or concepts to ensure compliance with industry standards, regulations, and company policies Preparing proposals for new projects, identifying potential problems, and proposing solutions Estimating costs and scheduling requirements for projects and evaluating results

Voltech Engineers Global is looking for Testing Commissioning Engineer to join our dynamic team and embark on a rewarding career journey Analyzing customer needs to determine appropriate solutions for complex technical issues Creating technical diagrams, flowcharts, formulas, and other written documentation to support projects Providing guidance to junior engineers on projects within their areas of expertise Conducting research on new technologies and products in order to recommend improvements to current processes Developing designs for new products or systems based on customer specifications Researching existing technologies to determine how they could be applied in new ways to solve problems Reviewing existing products or concepts to ensure compliance with industry standards, regulations, and company policies Preparing proposals for new projects, identifying potential problems, and proposing solutions Estimating costs and scheduling requirements for projects and evaluating results

Role Purpose The purpose of this role is to create content to convey complex, technical information to users using multiple techniques (writing, illustrations etc) as per client requirements and applicable quality standards Do 1. Prepare new technical content or update it for the clients Interact with SME (internal or Client) to gather and understand the client requirements (target audience), product documentation requirements as well as any specific content writing guidelines available specific to domain (eg, Oil & Gas or Aerospace) or as per industry standards Identify the list of documents (FAQs, product or software manuals, SOPs etc) to be prepared for the client Identify the appropriate authoring tools to be deployed Research, design, illustrate, write, revise, and edit high quality and user-friendly print documentations and manuals for end users of the clients Maintain and follow project tasks allocated including checklists and manage version control as per quality framework Mandatory Skills: Technical Writing. Experience: 5-8 Years.

Eurofins is the world leading Food Testing laboratory group, deploying a comprehensive range of state-of-the-art analytical techniques in order to support its clients' increasingly stringent quality and safety standards. We are present in India as Eurofins Analytical Services India Pvt Ltd and provide a comprehensive and one-stop testing service to businesses and organizations involved in food and feed processing, Agro products, Export, Hospitality and Retail chains. Maintenance and use of GC FID To test and analyze proximate parameters like UV parameters, Analysis of Fatty acids Maintaining samples before and after analysis Maintaining the CRM Method verification & validation SOP preparation Interpretation of the results. Qualifications 3-4 years experience of working in food testing laboratory. Proficient in handling Proximate analysis, water analysis, general instruments analaysis, Allergen analysis Graduate in B.Sc / M.Sc Chemistry Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. Job description: Planning/performing and reporting of acute toxicology studies Assist in preparation of SOP"™s, Protocols and Reports Participate in GLP / AAALAC related activities Literature search Maintenance of animal house and relevant documents as per GLP and AAALAC norms. To Assist and work along with SD and TC in Planning, initiation and conduct studies. Test item administration, dose formulation preparation and blood collection. Assistance in data collection, compilation and verification. Participate in GLP inspections and ensure relevant regulatory compliance guidelines. Support in interpretation and reporting of study data. Assist in report preparation and coordination of activities. Assist in archiving of all study related materials. Skills Required: Understanding of the agrochemical and pharmaceutical R&D process Behavioral Competencies: Good in oral / written communication skills. If you're interested in applying or learning more, send your updated resume to [email protected] with the subject line "Research Scientist/Senior Research Scientist - Acute "“ Toxicology - Bangalore". Qualifications Qualification M.Sc. in Zoology/Biosciences Additional Information Specialization Toxicology Department Acute "“ Toxicology Experience (years) 2 to 8 only

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.

Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

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

Responsible for following activities in purification area of BM/BU based on campaign basis 1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Execution of area, line clearance before execution of activities. Execution of product changeover activities. Responsible for column cleaning, packing, unpacking, evaluation and maintenance. Responsible for drug substance (FDS) transfer/dispensing. Execution of production activities. Monitoring and review of batch parameters/performance. Ensuring material are arranged properly before activities. Verification of samples for analysis. Responsible for shift Monitoring. Handling of online reject material. Review of soft copy for batch monitoring and performance. Execution of process validation. Execution of cleaning validation. Execution of verification protocols/equipment specific protocols. Ensuring buffer preparation in respective shift. 3. Handling of documents: Preparation of new / revision of SOPs, protocols and reports. Preparation of MFRs and BMR's. Primary review of executed BMR's submission to QA. Ensuring online BMR's updation and review of log books. 4. Responsible for monitoring and operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter TFF System Peristaltic pumps Weighing Balance Mixing Systems Biosafety cabinet Filter integrity tester pH meter Walk in cold Freezer room Heat Exchanger Mixing vessels Ensuring proper data backup of equipments. Provide clearance for calibration, PMP and validation of equipments. Participate in execution of equipment validations. 5. Responsible for Quality Management Systems Initiation / Review of breakdown request. Initiation of CRN's and Preparation of Risk Assessments. Initiation of incidents, investigation, CAPA. 6. Team member: Facility readiness for audits. 7. Training: Training team members on SOPs / GMP aspects. Attending training on related SOP's / GMP aspects. 8. Monitoring of PM/Qualification of purification area equipments. (Calibration / PMP/Qualification).ease enter job description

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. Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

To perform operation and changeover of the equipments like Vial Filling Stoppering Machine, Vial Cap Sealing Machine, Vial Washing Machine, Sterilizing and Depyrogenation tunnel, Lyophilizer, Autoclave, Pasteurizer, Incubator, Fogger and Filter integrity tester. Actively involve in fill finish operation and media fills. Preparation and review of general and equipment operation SOPs. Involve in preparation and reviewing of BMR, MFR Validation protocol etc. Compilation of all critical process attribute to analyze yield variation and investigation of low yield batches or OOS routed through change control or deviation. To get involve in external and internal regulatory audits and ensuring audit compliances.

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 to preparation review of standard operating procedures. 2.Responsible to ensure cGMP and GDP during document preparation and review. 3.Responsible for review of raw Material, packing Material and product testing etc., 4.Responsible to involve in change controls, deviations, CAPA and other QMS activities. 5.Responsible to involve in training management. 6.To involve in document control and archival procedures. 7.Responsible to review stability protocols and reports. 8.Should have good knowledge in Protein estimation procedures i.e. Biuret Kjeldahl methods and other Biological test methods. 9.Responsible to review HPLC, TOC, Gas chromatography data to ensure compliance with GLP and GMP standards. 10.Responsible to review of cross functional teams SOPs and other GMP documents. 11.To Involve in risk assessment procedures with the coordination of SMEs. 12.Coordination with cross functional teams like Production, QC, Projects, Engineering, Purchase, HSE etc. 13.Responsible to perform additional activities assigned by the superiors/Head of the department. 14.Responsible to review and compliance of regulatory filling activities as per established procedures.

1. Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

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. 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 compilation and review of validation raw data and test certificates. 5. Responsible for preparation and review of Computerized system validation (CSV) documents and execution of CSV for equipments. 6. Responsible for preparation of User Requirement Specification, Design Qualification, FAT protocols, SAT protocols, Installation qualification, Operational qualification and Performance qualification, 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 and review of risk assessments, deviation, change control and incidents related to qualification activities and user department activities. 11. Responsible for preparation of Utilities Annual summary reports.

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.

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.

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 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

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