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5.0 - 9.0 years
0 Lacs
lucknow, uttar pradesh
On-site
Job Description: You will be responsible for implementing and overseeing QA/QC protocols across all project stages. Your key responsibilities will include: - Conducting on-site inspections to verify construction quality and adherence to specifications. - Performing material testing and validation as per applicable standards. - Maintaining accurate QA/QC documentation, records, and checklists. - Monitoring and ensuring compliance with technical specifications. - Identifying non-conformance issues and recommending corrective and preventive measures. Qualification Required: - Degree in Civil Engineering Please submit your resume and cover letter highlighting your experience to hrdept@cstech.ai.,
Posted 20 hours ago
6.0 - 9.0 years
7 - 8 Lacs
ahmedabad
Work from Office
Prepare and compile DMF/ANDA Drug Substance modules (especially Module 2 & 3) in compliance with regulatory requirements. Review DMF submissions and respond to regulatory deficiencies and queries in a timely and accurate manner. Coordinate with internal teams (R&D, QA/QC, Manufacturing) and external stakeholders to gather and validate required documentation. Ensure alignment with FDA and ICH guidelines throughout the submission lifecycle. Monitor regulatory updates and proactively implement changes in submission strategy. Maintain regulatory documentation and track submission timelines and approvals. Participate in audits and inspections, providing regulatory support and documentation as needed. Required Skills: DMF/ANDA Drug Substance Module Preparation | Expert DMF Review & Deficiency Response | Advanced FDA & ICH Guidelines | Expert Regulatory Documentation & Submission Systems | Advanced
Posted 1 day ago
5.0 - 6.0 years
7 - 11 Lacs
mumbai
Work from Office
This position is accountable for execution of retrofit projects small to medium scale from post order to handover which involves planning , dispatch , site supervision and handover. Candidate must ready to travel outside office to client side on regular basis. He may need to stay 10 to 15 days outstation based on requirement. Receipt and review of Purchase Order / Technical specification of Customer. Preparation of BOM and indent according to contract scope. Kick off Meeting with customer for finalization of execution schedule Engineering Document development with the help of in-house design and engineering team Preparation, Submission & Approval from customer. Preparation & Release of indent (BOQ) for B/out items & fabricated items through SAP process ( PR ) Review & progress monitoring of fabricated items. Arrangement for QA /QC checks with 3rd party Monitoring of Dispatch as per invoicing plan. Periodic visit to site for execution supervision Complete work as per schedule within project budget and handover Recovery of Payments as per Contract Terms. Submission of project progress report to management
Posted 1 day ago
8.0 - 12.0 years
0 Lacs
noida, uttar pradesh
On-site
As a Civil Design Engineer at WSP, your role involves providing design solutions to civil engineering projects including High Voltage, Medium voltage, Low Voltage, Street Lighting, and Telecom networks for master plan, transportation, and highway projects. You will design right of way cross sections for all utilities, produce reports, drawings, calculations, and presentations. Your responsibilities also include liaising with local authorities regarding utility design proposals on behalf of the client, advising and presenting engineering solutions to clients and stakeholders, and submitting designs to local authorities for approvals. Your expertise in using Dialux, ETAP, Amtech, AutoCAD, Civil3D, Navisworks, and Microsoft Office will be essential for producing deliverables. Additionally, you will be involved in power analysis studies, design, and modeling, while ensuring compliance with QA/QC requirements and coordinating work with other disciplines. Qualifications: - BEng /BSc (Hon) or equivalent in Electrical or Electrical & Electronics Engineering with a minimum of 8 years post-graduate experience - Member of/working towards associated Professional body membership - Expertise in modeling of power and lighting networks - Proficiency in detailed design of engineering solutions - Strong report writing skills - Ability to compile authority approval documentation in accordance with local authority standards to obtain approvals About WSP: WSP is a global professional services consulting firm dedicated to local communities and driven by international expertise. With a team of technical experts, including engineers, technicians, scientists, architects, planners, surveyors, and environmental specialists, WSP designs lasting solutions in various sectors. With a presence in multiple locations globally and approximately 4,000 employees in India, WSP focuses on engineering projects that contribute to societal growth and development for the future. Inclusivity and Diversity: WSP values inclusivity and diversity in its workforce, fostering a close-knit community of over 73,300 talented professionals worldwide dedicated to making a positive impact. By joining WSP, you become part of a collaborative team that thrives on challenges, unconventional thinking, and innovative solutions for complex issues. Health, Safety, and Wellbeing: At WSP, health, safety, and wellbeing are integral to the work culture. The organization prioritizes a safe work environment and holds each individual accountable for fostering safety through initiatives such as Making Health and Safety Personal. With a Zero Harm Vision, WSP aims to reduce risks through innovative solutions, earning recognition for its global health and safety practices. Working Environment: WSP offers a hybrid working module that allows employees to operate in a flexible, agile, yet structured work environment. The focus is on maximizing collaboration, maintaining product quality, and balancing community, collaboration, opportunity, productivity, and efficiency. Join WSP today to access global opportunities, contribute to landmark projects, and collaborate with experts to shape a unique and fulfilling career.,
Posted 5 days ago
5.0 - 9.0 years
0 Lacs
chennai, tamil nadu
On-site
Job Description: You will be responsible for executing quality assurance and quality control for mechanical works, including conducting site inspections. Your qualifications should include a B.Tech or M.Tech in Mechanical Engineering. Additionally, you should have a minimum of 5 years of experience in the Oil & Gas industry. Key Responsibilities: - Execute QA/QC for mechanical works - Conduct site inspections Qualifications Required: - B.Tech or M.Tech in Mechanical Engineering - Minimum of 5 years of experience in the Oil & Gas industry,
Posted 5 days ago
10.0 - 20.0 years
8 - 18 Lacs
palghar
Work from Office
Job Title: Manager Quality Control (QC) Location: Palghar (Maharashtra) Qualifications & Experience: B.E./B.Tech/ Diploma in Metallurgy / Mechanical/ Production/Industrial Engineering or equivalent. 13-16 years of experience in Quality Control in a rolling mill or steel industry (preferably stainless steel). In-depth knowledge of mechanical properties, metallurgical characteristics of stainless steel, and forming behavior. Sound understanding of inspection techniques (UT, RT, MPI), lab testing (Spectro, UTM), and quality tools (SPC, 5 Why, FMEA, etc.). Key Skills: Expertise in stainless steel quality standards and rolling process parameters. Strong analytical and problem-solving skills. Proficiency in ISO documentation and audit processes. Leadership and people management skills. Excellent communication and inter-departmental coordination. Job Purpose: To lead and manage all quality control functions within the rolling mill operations, ensuring that stainless steel products meet customer specifications, national/international standards, and internal quality benchmarks across all shapes such as Rounds, Squares, RCS, Flats, Angles, Channels, Strips, I-Beams, and Hex sections. Key Responsibilities: Quality Management: Establish, implement, and maintain robust QC systems and procedures across all production lines. Monitor quality of incoming raw materials (billets) and coordinate with purchase/suppliers for corrective actions. Ensure in-process inspection and final product quality for all sections: round, square, flat, RCS, etc. Manage metallurgical testing (mechanical, chemical, ultrasonic, NDT as needed) of stainless steel products. Team Leadership: Lead and guide a team of QC Engineers, Inspectors, and Lab Technicians. Train and mentor QC staff on updated testing techniques and standards (ASTM, IS, DIN, etc.). Documentation & Compliance: Maintain comprehensive quality records, test certificates, and traceability documentation. Ensure adherence to ISO 9001 and other relevant quality certifications. Prepare and review quality manuals, control plans, and work instructions. Root Cause Analysis & Improvement: Lead investigation and analysis of quality complaints, rejections, and deviations. Drive corrective and preventive actions (CAPA), and initiate continual improvement programs. Coordination & Reporting: Liaise with production, maintenance, and planning teams to maintain quality standards. Prepare monthly quality reports and present to top management with KPIs like rejection rate, first-pass yield, customer complaints, etc.
Posted 6 days ago
6.0 - 10.0 years
0 Lacs
karnataka
On-site
As a Manager of Operations (Inspection) in the Renewable Energy industry, you will play a crucial role in overseeing and optimizing inspection and quality operations for solar and wind energy projects. Your responsibilities will include leading inspection operations, ensuring QA/QC compliance, managing manpower allocation, vendor relationships, stakeholder engagement, and reporting on project progress and quality status. You will drive adherence to industry standards, safety regulations, and support continuous improvement initiatives. To excel in this role, you must hold a Bachelor's degree in Engineering (Electrical/Mechanical/Renewable Energy preferred) and have 6 to 10 years of experience in QA/QC, inspection, or operations within the renewable energy sector, specifically solar and wind projects. Your technical expertise should include a deep understanding of solar PV systems, wind turbine components, knowledge of national and international QA/QC standards, and proficiency in inspection tools and documentation. In addition to your technical skills, you should possess strong leadership qualities, effective team management abilities, excellent stakeholder and vendor coordination skills, a problem-solving mindset with attention to detail, and exceptional verbal and written communication skills. Your willingness to travel to project and vendor sites frequently and exposure to utility-scale or large rooftop solar/wind projects would be advantageous for this role. If you meet these requirements and are passionate about driving quality and efficiency in renewable energy projects, we invite you to apply for the Manager of Operations (Inspection) position in Chennai, Kolkata, Bengaluru, or Hyderabad. Join us in our mission to contribute to the renewable energy sector and make a positive impact on the environment.,
Posted 6 days ago
2.0 - 6.0 years
0 Lacs
bangalore, karnataka
On-site
As a QS/QC Engineer (Civil) at Fineline Infra in Bengaluru, you will play a crucial role in our civil construction team by ensuring the highest standards of precision and excellence in our projects. Your responsibilities will include implementing and monitoring QA/QC procedures on-site, conducting site inspections and quality audits, ensuring compliance with GMP and industry standards, handling billing, BOQ preparation, and tender documentation, as well as collaborating with project teams to resolve quality issues. The ideal candidate for this position will have experience in QA/QC and Quality Management specifically in Civil Projects, possess knowledge of BOQ, Billing, and Tendering, demonstrate strong attention to detail and problem-solving skills, exhibit excellent communication and teamwork abilities, and hold a Bachelors degree in Civil Engineering or a related field. Certifications in QA/QC or Quality Management would be considered a plus. If you are passionate about building with quality and precision, we encourage you to apply for this exciting opportunity by sending your CV to finelineinfra.blr@gmail.com. Join Fineline Infra and contribute to our mission of delivering projects that meet the highest standards of quality and excellence.,
Posted 6 days ago
2.0 - 6.0 years
0 Lacs
pune, maharashtra
On-site
As a Quality Control Engineer at Arcatron Mobility Private Limited, you will play a crucial role in ensuring that our products meet the highest standards of quality and reliability. If you have a strong background in Quality Assurance/Quality Control (QA/QC) and are passionate about making a difference in the lives of individuals with mobility challenges, then this is the perfect opportunity for you. You will be responsible for developing and implementing quality control processes and procedures to ensure compliance with industry standards and regulations. Conducting regular inspections and testing of products to identify any defects or non-conformities will be part of your key duties. Working closely with the manufacturing team to address any quality issues and implementing corrective actions will also be essential tasks. Additionally, you will analyze quality data and metrics to identify trends and areas for improvement. Collaborating with cross-functional teams to ensure that quality standards are met throughout the product development process is crucial. Your role will also involve participating in the design and development of new products to ensure that quality requirements are met from the outset. Furthermore, training and mentoring junior quality control staff to ensure continuous improvement in quality processes and practices will be a significant aspect of your responsibilities. If you are a detail-oriented individual with a passion for quality and innovation, we invite you to join our team and help us in our mission to improve the lives of individuals with mobility challenges. Apply now to be a part of our exciting journey! Arcatron Mobility Private Limited is creating innovative devices to enhance the lives of the elderly and mobility-impaired individuals. The company is dedicated to uniquely addressing unmet needs, with a mission to "use technology to empower our consumers to lead a more active and safer lifestyle".,
Posted 1 week ago
5.0 - 7.0 years
5 - 7 Lacs
bengaluru, karnataka, india
On-site
Model building and drawings of building services elements for electrical services like lighting power, earthing and lightning protection systems, schematics, schedules, etc. Basic knowledge of electrical systems. QA/QC procedures Attention to quality and technical correctness Smooth coordination with other mechanical, structural and architectural services Work within time limits to complete deliverables on time. Candidate Specification : Have degree or diploma in electrical & electronics engineering Have 5 to 7 years of experience in electrical revit modelling for building services Be familiar with preparation of layout drawings and schematic diagrams for electrical services Be able to manipulate revit families creation, views, browser structure, sheets, schedules, filters and similar revit functions Navis work generation and clash coordination Basic knowledge in dynamo Have good written & verbal communication skills Be able to work without the help of mark-ups Exposure to platforms like BIM360 or project wise preferred We can offer (subject to Company s policy): Agile and safe working environment Competitive annual leave and sick leaves Group incentive scheme Group term life insurance, Workmen s compensation and Group medical insurance coverage Short and Long-term Global employment opportunities Global collaboration and knowledge sharing Digital Innovation and Transformation Equality, diversity and inclusion We put equality, diversity and inclusion at the heart of our business, seeking to promote fair employment procedures and practices to ensure equal opportunities for all. We encourage individual expression in our workplace and are committed to creating an inclusive environment where everyone feels they have the opportunity to contribute. Agile working At Mott MacDonald, we believe it makes business sense for you and your manager to choose how you can work most effectively to meet your client, team and personal commitments. We embrace agility, flexibility and trust. Role: Transportation Engineer Industry Type: Engineering & Construction Department: Construction & Site Engineering Employment Type: Full Time, Permanent Role Category: Construction Engineering Education UG: Diploma in Mechanical PG: Any Postgraduate
Posted 1 week ago
4.0 - 10.0 years
0 Lacs
haryana
On-site
You should have a minimum of 4-10 years of experience in Home furnishing/Soft Goods with US buyers. Your role will involve working on various embroidered products like pillows, bedding, table linen, Christmas products, etc. You should possess Quality Control (QC) ability from cut to pack and must have knowledge of shade matching, color understanding, Fabric/ product lab testing. Additionally, you should be proficient in writing emails, creating presentations, and working with Excel sheets. Your responsibilities will include preparing internal inspection reports on a daily basis and maintaining other quality records as required. It is mandatory to have your own mode of transport (2 Wheeler) to visit various contractors" facilities to review and control production. If you meet the qualifications and are interested in this position, kindly mail your updated resume with your current salary details to jobs@glansolutions.com. For more information, you can visit our website at www.glansolutions.com. Contact Satish at 88O2749743 for any queries. Make sure to mention key skills such as QA manager, QC, QA/QC, home furnishing export, home textile export, cut to pack QC, Embroidery, QA, quality manager, and quality controller in your application.,
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
noida, uttar pradesh
On-site
You will be responsible for developing, implementing, and maintaining the QA/QC plan and procedures for construction projects. It is essential to ensure that the quality control processes strictly adhere to the company's standards and all relevant local, state, and national regulations. Regular site inspections and audits need to be conducted to guarantee the implementation of quality standards. You will oversee the inspection of materials, equipment, and workmanship to ensure compliance with contract specifications. Maintaining detailed and accurate records of inspections, audits, and quality control tests is a crucial part of the role. Collaboration with project managers, engineers, and subcontractors is necessary to identify and resolve any quality issues that may arise. Additionally, conducting training sessions for the team on quality control and assurance procedures is part of the job responsibilities. Reviewing and approving quality-related documentation such as inspection and test plans (ITPs), method statements, and material submittals is also expected. It is essential to ensure that all non-conformance reports (NCRs) are addressed and rectified promptly. This is a full-time position with a day shift schedule, and the work location is in person.,
Posted 1 week ago
5.0 - 10.0 years
15 - 17 Lacs
bengaluru
Work from Office
Job Description : Model building and drawings of building services elements for electrical services like lighting power, earthing and lightning protection systems, schematics, schedules, etc. Basic knowledge of electrical systems. QA/QC procedures Attention to quality and technical correctness Smooth coordination with other mechanical, structural and architectural services Work within time limits to complete deliverables on time. Candidate Specification : Have degree or diploma in electrical & electronics engineering Have 5 to 10 years of experience in electrical revit modelling for building services Be familiar with preparation of layout drawings and schematic diagrams for electrical services Be able to manipulate revit families creation, views, browser structure, sheets, schedules, filters and similar revit functions Navis work generation and clash coordination Basic knowledge in dynamo Have good written & verbal communication skills Be able to work without the help of mark-ups Exposure to platforms like BIM360 or project wise preferred We can offer (subject to Company s policy): - Agile and safe working environment - Competitive annual leave and sick leaves - Group incentive scheme - Group term life insurance, Workmen s compensation and Group medical insurance coverage - Short and Long-term Global employment opportunities - Global collaboration and knowledge sharing - Digital Innovation and Transformation Equality, diversity and inclusion We put equality, diversity and inclusion at the heart of our business, seeking to promote fair employment procedures and practices to ensure equal opportunities for all. We encourage individual expression in our workplace and are committed to creating an inclusive environment where everyone feels they have the opportunity to contribute. Agile working At Mott MacDonald, we believe it makes business sense for you and your manager to choose how you can work most effectively to meet your client, team and personal commitments. We embrace agility, flexibility and trust.
Posted 1 week ago
2.0 - 6.0 years
0 Lacs
maharashtra
On-site
You will be responsible for ensuring the quality and precision of all engineering construction activities related to Piling, Civil, Architectural, and Structural disciplines. This includes overseeing multidisciplinary processes and maintaining high standards throughout the project. Your role will involve managing QA/QC documents for the entire project, which includes certificates, calibration records, test results, inspection requests, non-compliance reports, site instructions/observations, and other essential QA/QC documents. You will be tasked with developing and implementing standards for inspections and tests, monitoring testing methods, and upholding quality standards across all processes. Additionally, you will review the quality of materials on-site, ensure compliance with project specifications, and collaborate with the procurement department to source quality materials. This is a full-time position requiring a minimum of 2 years of total work experience. The work location is on-site.,
Posted 1 week ago
5.0 - 10.0 years
0 Lacs
haryana
On-site
At Jacobs, you are tasked with challenging today to reinvent tomorrow by addressing the world's most critical issues, contributing to the development of thriving cities, sustainable environments, essential outcomes, operational progress, scientific breakthroughs, and innovative manufacturing processes. Your role involves transforming abstract concepts into tangible solutions that positively impact the world. As the Document Controller at the construction site, your responsibilities include establishing and maintaining a comprehensive document control system for all project-related documents such as contract agreements, correspondence, diaries, drawings, reports, site order books, bills, and invoices. You will serve as the primary point of contact with the QA/QC Engineer for coordinating these activities and manage the company's document portals in alignment with the contract and project scope. Additionally, you will be responsible for systematically tracking, maintaining, and archiving project documents and Work Inspection Requests (WIRs) for future reference and client handover. To excel in this role, you should possess a Diploma/Bachelor's degree in Engineering, along with 5-10 years of relevant experience. It is crucial to have an understanding of your individual capabilities and technical proficiency, coupled with proficiency in written and spoken English. Effective communication skills will be advantageous in fulfilling your duties. Location: - Gurgaon, All IN Regions, India Join us at Jacobs to contribute to meaningful projects that shape a better future for communities and the environment.,
Posted 1 week ago
4.0 - 8.0 years
0 Lacs
maharashtra
On-site
The job reports to the Project Manager and is a full-time, exempt position. The primary areas of focus include QA/QC, basic design, modeling, and reports. As a part of the team, you will provide direction, coordination, and QA/QC to EITs, CAD Operators, and Designers. You will be responsible for designing simple projects such as grading, drainage, water/sewer, and utilities. You will draft complex report documents with minimal guidance and perform the final review of simple utility and drainage reports for approval. Additionally, you will develop complex models independently and lead meetings with clients and review agencies to present technical information. Your core responsibilities will also include monitoring compliance with applicable codes, practices, QA/QC policies, performance standards, and specifications. You will perform quality control on tasks, budgets, schedules, and plans, and report on the project status. Determining project specifications, preparing cross-sections for plan documents, and formatting base files for public works projects will be part of your routine. You will also be involved in performing design engineering on specific scopes or phases, basic hydraulic and hydrology calculations, and preparing specifications. It is essential to complete timecards accurately and on time, and you may be required to attend project team and public meetings after hours. Any other duties as assigned should be performed diligently. To excel in this role, you should aim to achieve a 75-85% Billable Utilization Rate. Non-billable activities may include company & team meetings, professional development, community involvement, innovation time, culture & engagement activities, learning, and training. Preferred skills and experience for this position include a Bachelor's or Master's degree in Civil, Environmental, Construction Management, or a related Engineering field. You should have a minimum of 4 years of experience in project planning and execution for land development projects, proficient knowledge of Microsoft Office, and exposure to scheduling software. Strong oral and written communication skills, the ability to work with multiple disciplines, excellent organizational, time management, leadership, and decision-making skills are essential. Knowledge of applicable codes, policies, standards, and best practices is also required. A valid driver's license and automobile insurance are necessary. Required licensure includes a Professional Engineering License. Physical requirements of the job may involve standing, walking, sitting, occasional visits to project sites, a normal range of hearing, lifting up to 40 lbs. occasionally, prolonged sitting with bending and reaching, manual dexterity to operate a computer keyboard and calculator, and noise levels consistent with a standard office environment. The perks and benefits offered with this position include health, life, 401(k), dental, and vision insurance, short-term and long-term disability insurance and leave, paid holidays, paid time off, bereavement leave, and discretionary bonuses if applicable.,
Posted 1 week ago
5.0 - 6.0 years
7 - 8 Lacs
mumbai
Work from Office
Job Title: Project Engineer Function / Department: Service About Wipro Water Wipro Water is a Business Unit of Wipro Infrastructure Engineering (a division of Wipro Enterprises Ltd) headquartered in Mumbai. Wipro Water offers Complete Solutions in Water & Waste Water Treatment, O&M, Desalination, Sustainability Consulting, Recycle & Reuse, Sludge Treatment and Source Analysis. Website: www. wiprowater. in Desired Candidate Profile: Qualifications: Desired Experience: Yrs of Exp / Nature of Exp BE Mechanical / Diploma Mechanical 5 to 6 Yrs. in Medium Project Execution in Water and Waste Water domain Key Skills Required: Areas of expertise / skills Understanding of Water and Waste water treatment Project Schedule Planning and Execution and invoicing as per plan Erection and Commissioning knowledge of Water and Waste Water treatment SAP based execution knowledge will be considered as added advantage Target Companies: Thermax Ion Exchange Position Details Key Accountabilities: List the key areas of responsibility This position is accountable for execution of retrofit projects small to medium scale from post order to handover which involves planning , dispatch , site supervision and handover. Candidate must ready to travel outside office to client side on regular basis. He may need to stay 10 to 15 days outstation based on requirement. Receipt and review of Purchase Order / Technical specification of Customer. Preparation of BOM and indent according to contract scope. Kick off Meeting with customer for finalization of execution schedule Engineering Document development with the help of in- house design and engineering team Preparation, Submission & Approval from customer. Preparation & Release of indent (BOQ) for B/out items & fabricated items through SAP process ( PR ) Review & progress monitoring of fabricated items. Arrangement for QA /QC checks with 3rd party Monitoring of Dispatch as per invoicing plan. Periodic visit to site for execution supervision Complete work as per schedule within project budget and handover Recovery of Payments as per Contract Terms. Submission of project progress report to management Reporting: Mention reporting relationships Head Service Business Work Location Airoli, Navi Mumbai Budgeted CTC To be discussed at the time of interview
Posted 1 week ago
3.0 - 8.0 years
8 - 13 Lacs
ahmedabad
Work from Office
Plan and execute mechanical engineering tasks for pharma projects. Review BOQs, layouts, and specifications for HVAC and utility systems. Ensure installations meet cGMP, FDA, IS, and ASME standards. Coordinate with QA, QC, Production, EHS, and Maintenance teams. Monitor project schedules using MS Project or Primavera. Manage vendors, contractors, and technical meetings. Conduct FAT/SAT and qualification protocols (DQ, IQ, OQ). Maintain documentation for audits and regulatory compliance. Uphold safety, quality, and statutory norms.
Posted 1 week ago
1.0 - 2.0 years
3 - 4 Lacs
hyderabad
Work from Office
Career Category Regulatory Job Description Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen s CMC submission execution team, R egulatory O ptimization o f T actical and S trategic S upport (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC and/or Device documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product and/or Device timelines at the direction of product lead Interface with the regulatory operations team Train staff on select procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master s degree OR Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Experience in IVD, Device or Combination Product regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms .
Posted 1 week ago
2.0 - 8.0 years
4 - 10 Lacs
baddi
Work from Office
Followings will be the Core Job responsibilities of the position holder: 1. Ensure the compliance to laid standards of the good manufacturing practices. 2. Organizing the job responsibilities to the technicians as per daily plan and execute the defined targets as per standard outputs. 3. To ensure maintenance of Production Area and Equipments in the state of cleanliness as per the SOPs at all points of time. 4. To carry out routine documentation as per Regulatory Requirements and to complete BMR timely with all respects. 5. Continuous monitoring and improving the production output on daily basis and control on absenteeism of Technicians. 6. Continuous monitoring of In-process controls in production areas. 7. To fill and maintain the BMR online. 8. To maintain /fill the formats and other related documents and the to provide the training to the technicians. 9. Coordination with production Planning department for process order and Batch Record document with QA. 10. Checking of dispensed input materials against process orders. 11. Co-ordination for installation and Qualification of Production equipment. 12. To exercise effective control over the environmental conditions in Manufacturing and other related activities, which may adversely affect the product quality. 13. Compliance to specifications and Validated methods 14. To co-ordinate for calibration / preventive maintenance for all production equipments and instruments with engineering / QA / QC & outside agencies. 15. To work within the specified working hours. 16. Raising requisition for the requirements of Consumables related to production activities. 17. Handling of online systems and software such as SolTRAQs, Isotrain, Darius. 18. Preparation of Standard Operating Procedures, for related equipment s and procedures. 19. Training and evaluation of the Production Technicians for their qualification to specific task or to operate specific equipment. 20. Ensure compliance of SAP activities related to updation of BOM, creation of new item codes and regularizes the SAP entries. In absence of the position holder, the sub-ordinate Executive/ Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working. t SIGNIFICANT WORK ACTIVITIES: Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Posted 2 weeks ago
5.0 - 9.0 years
4 - 9 Lacs
dahej, ahmedabad, vadodara
Work from Office
Dear Sir, Pls fin the below details, Client Name - Reliance Industries Ltd Payroll Company - On roll Total Exp 5-8 Year CTC- 80 to 84 K+ Travel Conveyance(Laptop & Accommodation & Food in candidate scope) Location Dajeh GJ Designation Quality Assurance/Quality Cont Local conveyance in our scope Accommodation in candidate scope. 12 Hours working. JD attached Quality Assurance/Quality Control Engineers 5+ exp Certification ASNT/ISNT level II Question for Candidate :- Quality Assurance/Quality Control Current SOW Piping works exp Difference between ASME 31.1 AND 31.3 Category of fluid service MOC LTCS and what is grade LTCS welding How to identify LTCS pipes PMI of pipes Have you done any post weld heat treatment Review of radiography films What are things to be inspected in radiography What are minimum required data in radiography film If you have some of lines having 5 % NDT, how to cover it in entire line. For forging pipe, what are specification to be used. Alloy steel knowledge Essential variable during welder qualifications. Position and thickness in essential variable One vendor qualified in carbon steel GTW . can I use him in stainless steel GTW ? F number of E 7018 Electrode Welding procedure specifications WPS. PAUT exposure. Can you interpret ultrasonic testing What is standard gap min & max If stack welding not allowed in pipe joint, which process to follow. Criteria for purging , how to know it is ready to weld
Posted 2 weeks ago
5.0 - 9.0 years
0 - 0 Lacs
karnataka
On-site
A leading Construction Company is seeking suitable candidates for the position of QA/QC Engineer in Bangalore. The ideal candidate should have a Diploma/BE in Civil Engineering with 5 to 7 years of experience in the field. As a QA/QC Engineer, you will be responsible for ensuring the quality and precision of all activities related to engineering construction, specifically in Civil, Architectural, and Structural disciplines. Your duties will include managing QA/QC documents for the entire project, overseeing inspections and tests, and maintaining high-quality standards throughout all processes. You will be required to review the quality of materials on-site, ensure compliance with project specifications, and collaborate with departments for material procurement. Additionally, you will supervise the implementation of test and inspection schedules, conduct quality audits, and ensure adherence to all procedures. Furthermore, you will assist employees in understanding quality standards, work with contractors and suppliers to maintain quality systems, and manage the storage of hazardous materials. You will also be responsible for recording project activities, analyzing processes, and recommending corrective actions for operations. In this role, you will develop method statements for activities, liaise with Technical Engineers for material submittals, and coordinate with Consultants" representatives and Site In-charge for inspections. Your attention to detail and commitment to quality assurance will be crucial in ensuring the successful completion of projects. If you meet the qualifications and are interested in this opportunity, please contact us at 9035007003, 9845264304, 9035302302, or email your resume to placements@beechi.in. Join our team and be a part of our dynamic construction projects in Bangalore.,
Posted 2 weeks ago
1.0 - 5.0 years
0 Lacs
ahmedabad, gujarat
On-site
The ideal candidate should possess a high school diploma or equivalent, with a preference for a Bachelor's degree. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) is essential for this role. Good communication skills and the ability to work well with others are key qualifications. Attention to detail, accuracy, multitasking, and effective prioritization are important attributes for success in this position. Knowledge of office equipment such as printers and fax machines is required. A minimum of 1+ years of experience in a relevant field is preferred for this role. The job type is full-time, and the work location is in person. Education: - Bachelor's degree (Preferred) Experience: - 1 year in Pharma (Preferred) - 1 year in QA/QC (Preferred) - 1 year in quality checks on raw materials (Preferred) - 1 year in Quality assurance (Preferred),
Posted 2 weeks ago
17.0 - 18.0 years
25 - 30 Lacs
ahmedabad
Work from Office
Designing and optimizing scalable DSP processes for peptide purification. Selecting and commissioning DSP equipment aligned with regulatory and operational requirements. Leading the setup of PD and GMP facilities, ensuring seamless integration of DSP workflows. Managing technology transfer from global partners, ensuring knowledge capture and implementation. Driving process optimization initiatives to improve yield, purity, and cost-efficiency. Collaborating with cross-functional teams including R&D, QA/QC, Engineering, and Regulatory Affairs. Exploring and implementing new platform technologies for next-generation peptide manufacturing.
Posted 2 weeks ago
2.0 - 6.0 years
4 - 8 Lacs
bengaluru
Work from Office
Data QA/QC Analyst Job Description: We seek a highly skilled and detail-oriented individual to join our team as an Excel Specialist. The ideal candidate will have an exceptional command of Microsoft Excel, with expertise in data analysis, spreadsheet management, and creating complex macros. Key Responsibilities: Develop and implement Excel-based solutions to automate tasks and improve workflow efficiency. Create macros to visualize data and facilitate decision-making. Collaborate with various departments to understand their data needs and provide Excel-based solutions. Perform data validation, clean-up, and reconfiguration tasks to ensure data accuracy and integrity. Train and support colleagues in utilizing Excel functionalities and best practices. Proficiency in Microsoft Excel Ability to interpret complex data with strong analytical and problem-solving skills. Experience in data analysis, reporting, and manipulation using Excel. Attention to detail and accuracy in managing and organizing large datasets. Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams. Ability to prioritize tasks and manage time efficiently in a fast-paced environment. Qualifications: Proficient in Microsoft Excel Certification in Microsoft Excel or related courses (desired) Bachelor s degree in Business, Finance, Information Technology, or a related field (preferred) Experience in MEP Construction is a plus
Posted 2 weeks ago
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