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6.0 - 10.0 years
8 - 15 Lacs
Mumbai
Work from Office
Role & responsibilities MAJOR ACCOUNTABILITY (Mention core tasks assigned to associate etc.) 1. Preparation of Qualification documents for Pharmaceutical HVAC system. - URS, DQ, IQ, OQ, PQ 2. Execution of HVAC modification projects 3. Review of HVAC assessment reports for modification scope of HVAC systems 4. Review of BOQ for HVAC modification 5. Preparation of URS for Air Handling Systems 6. Preparation of QRA & CR for HVAC modification projects 7. Review of HVAC layouts i.e. System zoning, Pressure Zoning, Area Classification drawings 8. Review of Heat Load calculations 9. Integration of new AHUs with BMS system & BMS system qualification 10. Creation of Maintenance plan, Calibration plan...
Posted 3 months ago
6.0 - 10.0 years
5 - 9 Lacs
Mumbai
Work from Office
Role & responsibilities 1. Preparation of Qualification documents for Pharmaceutical OSD Process Equipments. - URS, DQ, IQ, OQ, PQ 2. Execution of IQ, OQ & PQ of Process Equipments 3. Execution of modification projects 4. Review of Process Equipments layouts & associated utilities 5. Review of Process Equipment Vendor PFDs & PIDs 6. Preparation of URS for Process Equipment’s 7. Preparation of QRA & CR for modification projects 8. Creation of Maintenance plan, Calibration plan for Process equipment’s 9. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. 10. Completion of all trainings assigned to role 11. Ensure integrity of data at workplace. 12. Ensure Good Do...
Posted 3 months ago
8.0 - 9.0 years
0 Lacs
Navi Mumbai
Work from Office
The candidate should be aware of Netapp storage structure. Which will cover the basics of Netapp. Must be aware of Cloning processes. Must be aware of Data protection & storage efficiency. Share your CV to ruban@futuresolution.co.in
Posted 3 months ago
7.0 - 9.0 years
27 - 42 Lacs
Chennai
Work from Office
Job Summary The ideal candidate will have a robust skill set particularly in Jenkins uDeploy GitHub actions Aws devops Nexus and Nexus IQ. Responsibilities The ideal candidate will have a robust skill set particularly in Jenkins uDeploy github actions Aws devops Nexus and Nexus IQ. The primary responsibilities will include managing and maintaining our continuous integration and continuous deployment (CI/CD) systems using Jenkins. They should be proficient in creating configuring and troubleshooting Jenkins pipelines to ensure smooth and efficient software delivery. Additionally experience with uDeploy is essential. The candidate will be responsible for automating and streamlining our applica...
Posted 3 months ago
3.0 - 7.0 years
3 - 7 Lacs
Hyderabad
Work from Office
Role Description? This role involves working closely with Business Analyst Data architects, Data engineers, AI/ML engineers and Product Managers to ensure that Validation strategy and deliverables are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise , validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validatio...
Posted 3 months ago
7.0 - 12.0 years
10 - 14 Lacs
Bengaluru
Work from Office
Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Finastra Fusion Loan IQ Good to have skills : Java, Spring BootMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your day will involve overseeing the application development process and ensuring seamless communication within the team and stakeholders. Roles & Responsibilities:- Expected to be an SME- Collaborate and manage...
Posted 3 months ago
8.0 - 13.0 years
10 - 14 Lacs
Bengaluru
Work from Office
Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Finastra Fusion Loan IQ Good to have skills : Java, Spring BootMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your day will involve overseeing the application development process and ensuring seamless communication within the team and stakeholders. Roles & Responsibilities:- Expected to be an SME- Collaborate and manage ...
Posted 3 months ago
7.0 - 12.0 years
10 - 14 Lacs
Bengaluru
Work from Office
Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Finastra Fusion Loan IQ Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your day will involve overseeing the application development process and ensuring seamless communication within the team and stakeholders. Roles & Responsibilities:- Expected to be an SME- Collaborate and manage the team to pe...
Posted 3 months ago
5.0 - 8.0 years
9 - 12 Lacs
Bengaluru
Work from Office
The New Product Manufacturing Engineer (NPME) is responsible for ensuring smooth and compliant transition of new medical devices from design to manufacturing. This role plays a critical part in developing scalable, validated manufacturing processes, driving design for manufacturability (DFM), and executing Verification and Validation (V&V) activities in alignment with ISO 13485 and FDA 21 CFR Part 820. Key Responsibilities: Collaborate with R&D during the design phase to influence DFM and ensure manufacturability. Plan, execute, and document manufacturing Verification & Validation (V&V) activities, including equipment and process validations (IQ, OQ, PQ). Lead development of process document...
Posted 3 months ago
3.0 - 8.0 years
3 - 6 Lacs
Ahmedabad
Work from Office
Job Location: Ahmedabad Experience Year : 3+ Years Qualification: Bachelors Position: QA-CSV Job Type: WFO Company Name: GSC Technolabs. A Group of GSC Technologies Ltd. Key Job Responsibilities for a QA-CSV Role: Validation Planning: Develop and maintain Validation Master Plans (VMP). Define validation strategy based on risk and regulatory impact. Documentation: Create and review validation documentation including: User Requirements Specifications (URS) Functional Specifications (FS) Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) Traceability Matrix Final Validation Reports Testing & Execution: Lead or perform Installation Qualification (IQ), Operational Qualification (OQ), an...
Posted 3 months ago
5.0 - 8.0 years
10 - 14 Lacs
Bengaluru
Work from Office
Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP FI S/4HANA Accounting Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Person must be having good experience on SAP FI. Must be having good experience on CR, Writing FS etc.As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing...
Posted 3 months ago
5.0 - 8.0 years
7 - 8 Lacs
Bhiwadi
Work from Office
Role & responsibilities Review design of new HVAC & BMS (Building Maintenance System) with Utilities team Ensure project execution as per P&G approved design. Provide design improvement ideas for Utilities to enable energy and water saving ideas. Suggest technical improvements in Utility equipments working in Operations and Engineering team. Support detailed design reviews ensuring proposed solutions meet P&G technical standards. Work with site resources to execute the projects. Prepare BOM for HVAC System, compressor system and water treatment system. Assess BOQ supplied by designer and get corrections done. Daily monitoring of project execution work as Utilities SPOC. Get validation done a...
Posted 3 months ago
5.0 - 8.0 years
7 - 8 Lacs
Alwar
Work from Office
Role & responsibilities Review design of new HVAC & BMS (Building Maintenance System) with Utilities team Ensure project execution as per P&G approved design. Provide design improvement ideas for Utilities to enable energy and water saving ideas. Suggest technical improvements in Utility equipments working in Operations and Engineering team. Support detailed design reviews ensuring proposed solutions meet P&G technical standards. Work with site resources to execute the projects. Prepare BOM for HVAC System, compressor system and water treatment system. Assess BOQ supplied by designer and get corrections done. Daily monitoring of project execution work as Utilities SPOC. Get validation done a...
Posted 3 months ago
6.0 - 11.0 years
7 - 12 Lacs
Hyderabad
Work from Office
At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and doc...
Posted 3 months ago
8.0 - 10.0 years
8 - 11 Lacs
Bengaluru
Work from Office
Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the o...
Posted 3 months ago
5 - 8 years
7 - 10 Lacs
Bengaluru
Work from Office
About The Role Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. ? Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to...
Posted 4 months ago
4 - 9 years
0 - 0 Lacs
Bengaluru
Work from Office
Strategic: Representative for QMS activities in Drug product/ Drug substance area. Timely initiation and closure of QMS elements. Documentation related to Drug product/ Drug substance area. Training need identification for all the employees Assist the validations and routine validations of equipment and facility. Identify and implement the manufacturing and warehouse procedures with compliance to current GMP requirements. Coordination during customer and vendor audits. Coordinating with engineering and validation department for calibration and preventive maintenance. Coordination and implementation of software based QMS solutions like Track-wise, LMS, SAP etc. Operational: Initiation of chan...
Posted 4 months ago
20 - 30 years
500 - 1000 Lacs
Baddi
Work from Office
Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. C...
Posted 4 months ago
5 - 7 years
4 - 6 Lacs
Visakhapatnam
Work from Office
Role & responsibilities Utility Executive : 1. Responsible for Operation, Maintenance of Block Utilities & Central Utilities.. 2. Responsible for ordering, maintain stock of spares, consumables required for the machines & facility. 3. Responsible for implementation of Preventive Maintenance activities as per schedule. 4. Execution of Qualification documents. 5. Preparation of SOPs and reviewing of daily log sheets. 6. Responsible for Change Controls & Deviations. 7. Responsible for breakdown analysis &CAPA. 8. Responsible for Energy conservation in Utilities. 9. Responsible for up gradation in utility systems. 10. Responsible for minimising break downs & Improving efficiency of utility syste...
Posted 4 months ago
5 - 10 years
10 - 20 Lacs
Hyderabad, Delhi / NCR, Mumbai (All Areas)
Work from Office
Job Description Must Have: Experience in handling Clients and Stakeholder interactions. Well versed with CSV and GxP process and ability to adopt to client Process, systems and documentation needs like Test Protocol, Test Plan, Test Strategy, IQ/OQ/PQ scripts, RTM, Test Summary Report etc., Understanding of various SDLC methodologies(Agile, Waterfall, V) Flexibility to Work as per Customer timings Generate Automation Test Strategy for applications deployed on Cloud. ( Public and Private cloud) Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. Working experience in testing Restful Webservices and APIs using frameworks or tools like...
Posted 4 months ago
4 - 9 years
4 - 7 Lacs
Hyderabad
Work from Office
Candidates experience with ISO 15378/GMP, ISO 13485, and IQ, OQ, and PQ, particularly in relation to the pharmaceutical industry. Position :- Quality Assurance- Engineer- No of positions:- 1 Location:- Isnapur- Hyderabad Preferred candidate profile
Posted 4 months ago
2 - 4 years
0 - 1 Lacs
Navi Mumbai
Work from Office
Qualification : Bachelor's degree in a related field or equivalent work experience. Years of experience : 1 to 4 Years relevant experience Required skills : Proven experience in technical document control or a related field. Strong knowledge of document management software and tools. Attention to detail and the ability to work with complex technical documents. Familiarity with project management Familiarity with industry standards and regulations related to documentation. Roles & Responsibilities Manage and control all technical documents, including engineering drawings, manuals, specifications, and procedures Ensure that all technical documentation adheres to regulatory and quality standard...
Posted 4 months ago
2 - 6 years
7 - 11 Lacs
Hyderabad
Work from Office
What you will do Role Description: The Sr. Validation Engineer – Clinical Computation Platform will support the validation and operational management of clinical computation platforms at Amgen, ensuring the integrity and compliance of critical systems and data. This role involves collaboration with various Amgen teams to enhance and secure clinical operations This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance o...
Posted 4 months ago
3 - 8 years
3 - 7 Lacs
Hyderabad
Work from Office
ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-fun...
Posted 4 months ago
10 - 15 years
22 - 37 Lacs
Hyderabad
Work from Office
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role Are you passionate about delivering exceptional service and revolutionizing the world of technology? We have an incredible opportunity for a talented individual to join our dynamic team as a Plant IT Operations Lead. In this customer-centric role, you will play a pivotal role in ensuring our customers receive top-notch service within a contract...
Posted 4 months ago
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