840 Capa Jobs - Page 7

Role Purpose The purpose of this role is to conduct audits to ensure quality compliance within the account. Do Conduct process quality audits as per plan Conduct various process audits (1 audit/ agent/ week) as per procedure and guidelines For agents identified in the bottom quartile of performance, conduct 3 audits/ agent/ week Prepare findings from the report and share it with the client and the account leadership on daily/ weekly/ monthly, as required Conduct weekly analysis to identify the error trends and for top 2 errors, conduct root cause analysis (RCA) Conduct calibration communication to communicate any changes from the client and conduct refresher trainings to bridge any skill gap due to these changes. Mandatory Skills: L&P Policy Acquisition & Servicing. Experience: 1-3 Years. >

Post - QMS -Manager Qualification : BE Electrical or Electronics Location Pune chakan Contact - 9356395439 Email - jobpune12@gmail.com Experience : 5 + yrs experience in control Panel manufacturing Salary : No bar for the right candidate. QMS Development and Implementation: Establishing and maintaining the QMS according to relevant standards like ISO 9001, AS9100, or IEC 61439-1 & 2, as applicable. Compliance: Ensuring adherence to all relevant standards, regulations, and customer requirements. Documentation: Managing and controlling QMS documentation, including procedures, work instructions, and control plans. Audits: Conducting internal audits, coordinating external audits, and managing responses to audit findings. Non-Conformance Management: Identifying, investigating, and resolving non-conformities, implementing corrective and preventative actions (CAPA). Customer Complaints: Managing customer complaints, conducting root cause analysis, and implementing preventive measures.

1. Monitoringof Site Activities 2. FindingUnsafe Acts Unsafe conditions and escalating the same to plant HSE leadclearing the same on shop floor by the deviated departments. 3. Supportingto plant HSE Lead in the HSE functions/ activities/ procedures in relateddocumentations as per the department requirements. 4. Ensuringto impart the Tool Box Talks to workmen or conducting by the supervisors priorto the work activities. 5. Updatingthe HSE documentation on regular basis. 6. Ensuringthe contractors workmen to follow the HSE policies procedures as per theHetero Plasma Sciences Pvt Ltd. 7. Monitoringthe vendors/ contractors at site during execution of works and their sitevisits. 8. Regularsite inspections/ site rounds. 9. Ensuringto monitor the activities whether they (Hetero team/ contractor workmen) areadhering to work permits or not and raising the deviation as per the violation. 10. Planningdoing the HSE activities at site as per the HSE planner by coordinatingwith cross functional departments. 11. Periodicchecking inspection of Safety Emergency equipments and clearing its gapsif there will any by the support of concerned departments.

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.

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.

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. 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 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 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. 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.

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.

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.

Responsible for entire QC function. Ensure RM/SFG/FG specs Ensure effective RCA/implement CAPA as req Oversee QMS/FSSC/BRC systems concerning GMP/labs Lead ISO 17025/NABL accreditation Ensure FTR performance/ lab 5S practices Required Candidate profile 18+ years in leading QC function in food companies . Job location is Kochi, Kerala Exp in leading large teams

Doing inspection of automobile & electrical parts

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

Job description Role and Responsibilities: Proficient and hands on experience in all kinds of precision measuring instruments and its calibrations. Able to read and understand the Engineering drawings Hands on experience in NDT techniques Knowledge of raw material specifications and review of material test certificates. Knowledge of ISO Documentation. Proficient in Quality Tools like NC Management, Root Cause Analysis, CAPA, FMEA, 8D, 5 Why Planning, organization, and coordination of inspections at supplier facilities. Preparation, execution, and follow-up of non-destructive tests on steam turbines and associated components Supplier qualification, development, and active participation in the quality improvement of suppliers and purchased parts. Avoiding quality problems by developing preventive measures for suppliers Methods for quality assurance and analyzing the causes of defects and initiating appropriate corrective measures together with suppliers & in-house. Initiating, monitoring and actively pursuing corrective and preventive actions for repair parts Proactive collaboration with internal stake holders. Knowledge on SAP material master for quality inspections & GRN clearances. Good Communication skills in English Read, Write and Speak Good command on MS office tools Ready to travel across the country for vendor inspections. Experience in turbo machineries desirable Education & experience: B.E Mechanical or equivalent degree Certified ASNT NDT Level II in UT, MPT, LPT and VT 5 to 10 years of relevant professional experience Profound knowledge in the application of quality methods, such as 5 Why, FMEA, 8D, RCA Very good collaboration and communication skills required. Confident handling of MS Office applications and SAP Team player, precise work, high level of initiative and flexibility Constructive collaboration across all functions Willingness to travel for site support

Role and Responsibilities: Proficient and hands on experience in all kinds of precision measuring instruments and its calibrations. Able to read and understand the Engineering drawings Hands on experience in NDT techniques Knowledge of raw material specifications and review of material test certificates. Knowledge of ISO Documentation. Proficient in Quality Tools like NC Management, Root Cause Analysis, CAPA, FMEA, 8D, 5 Why Planning, organization, and coordination of inspections at supplier facilities. Preparation, execution, and follow-up of non-destructive tests on steam turbines and associated components Supplier qualification, development, and active participation in the quality improvement of suppliers and purchased parts. Avoiding quality problems by developing preventive measures for suppliers Methods for quality assurance and analyzing the causes of defects and initiating appropriate corrective measures together with suppliers & in-house. Initiating, monitoring and actively pursuing corrective and preventive actions for repair parts Proactive collaboration with internal stake holders. Knowledge on SAP material master for quality inspections & GRN clearances. Good Communication skills in English Read, Write and Speak Good command on MS office tools Ready to travel across the country for vendor inspections. Experience in turbo machineries desirable Education & experience: B.E Mechanical or equivalent degree Certified ASNT NDT Level II in UT, MPT, LPT and VT 5 to 10 years of relevant professional experience Profound knowledge in the application of quality methods, such as 5 Why, FMEA, 8D, RCA Very good collaboration and communication skills required. Confident handling of MS Office applications and SAP Team player, precise work, high level of initiative and flexibility Constructive collaboration across all functions Willingness to travel for site support

Job description Quality Culture: Ensure awareness for quality focus to increase customer satisfaction, particularly in the development process Plan, implement and live Quality culture within Product Line and organization level (Implement the defined processes, improve product quality, initiate process improvements, and drive continuous improvements (CI) in projects) Ensuring compliance (of products) with legal and normative requirements (including tailoring of processes as appropriate) Effectively review product risk management activities (including Risk Analysis, Risk Management Report) Collaborate with onsite teams to keep project teams aligned with headquarters expectations Drive best practices within the organization Quality Management: Define quality strategy in Quality Management Plan Drive process compliance in the complete lifecycle process of the medical device - starting with product definition till End of Support Act as independent reviewer for design reviews acc to QSR 820.30 (e) with the responsibility of defining and documenting the overall result of the design review. Work with internal delivery team and other functions in order to meet the specified Quality Goals of the project Supporting and consulting of employees in implementing and realizing the processes as we'll as decision about tailoring of defined processes - both according to the needs of the business and in compliance with statutory requirements Identify opportunities to improve productivity and efficiency with lower costs, reduce non-conformance costs Initiate and moderate the root cause analysis and monitor effective and timely implementation of CAPA Reporting and Coordination: Prepare and provide input to the periodic reports as needed by headquarter team Audits and Assessments: Conduct / Participate in Internal Audit and External Audits using MDSAP methodology. Coordinate and ensure timely closure of audit findings Qualification Requirements Bachelors or Masters in Engineering / MCA having an excellent academic track record. Proficient in managing Quality of complete Software Medical Device Development lifecycle in distributed international environment. Experienced in latest trends of Software Product Development (eg Trunk Based Development, Continuous Delivery (DevOps) etc) Advanced Knowledge of standards and regulations like ISO13485, ISO 14971 and 21CFR820 QSR (knows in detail and practical application in regards to the Quality Management System) Advanced knowledge of quality tools for Metrics data analysis and decision making Advanced computer skills (MS Office tools like Word, Access, Excel, PowerPoint and Outlook) Highly energetic and Go-getter Proven ability to independently plan and successfully execute multiple projects based on business priorities. Display of a high level of critical thinking in bringing successful resolution to high-impact, complex and cross-functional problems is expected. Advanced knowledge of organizations business practices and issues faced and contributions to problem resolution of those issues. Excellent organizational and communication skills (eg Moderation, presentation to all levels). Auditor experience in Medical Device area is preferred. 12 to 16 years of successful experience in Quality Management and demonstration of Key Responsibilities and Knowledge as mentioned above. Advanced degree MAY be substituted for experience, where applicable

About Company Founded in 2011, ReNew, is one of the largest renewable energy companies globally, with a leadership position in India. Listed on Nasdaq under the ticker RNW, ReNew develops, builds, owns, and operates utility-scale wind energy projects, utility-scale solar energy projects, utility-scale firm power projects, and distributed solar energy projects. In addition to being a major independent power producer in India, ReNew is evolving to become an end-to-end decarbonization partner providing solutions in a just and inclusive manner in the areas of clean energy, green hydrogen, value-added energy offerings through digitalisation, storage, and carbon markets that increasingly are integral to addressing climate change. With a total capacity of more than 13.4 GW (including projects in pipeline), ReNew’s solar and wind energy projects are spread across 150+ sites, with a presence spanning 18 states in India, contributing to 1.9 % of India’s power capacity. Consequently, this has helped to avoid 0.5% of India’s total carbon emissions and 1.1% India’s total power sector emissions. In the over 10 years of its operation, ReNew has generated almost 1.3 lakh jobs, directly and indirectly. ReNew has achieved market leadership in the Indian renewable energy industry against the backdrop of the Government of India’s policies to promote growth of this sector. ReNew’s current group of stockholders contains several marquee investors including CPP Investments, Abu Dhabi Investment Authority, Goldman Sachs, GEF SACEF and JERA. Its mission is to play a pivotal role in meeting India’s growing energy needs in an efficient, sustainable, and socially responsible manner. ReNew stands committed to providing clean, safe, affordable, and sustainable energy for all and has been at the forefront of leading climate action in India. Job Description Knowledge of contractor assessment Interaction with 3rd party inspection agencies Monitoring of work done by 3rd party engineers Knowledge of ISO 9001 requirements. Knowledge of preparation and verification of RCA and Corrective actions. Imparting Job specific trainings. Knowledge of the various standards applicable in Solar/Power installations. Knowledge about testing and commissioning. Preparation of Field Quality plans, SOP’s ,Work instructions.