332 Oq Jobs - Page 7

I am looking for a database resource for Integral IQ that is suitable for professionals with 2-4 years of experience and a strong foundation in database concepts

Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM

Job Title: Computer System Validation (CSV) Specialist Regulatory Compliance & QA Location: Hyderabad Experience: 3 to 6 Years About the Role: A leading MNC is hiring skilled Computer System Validation (CSV) Specialists to support regulatory compliance, QA, and governance for validated systems and infrastructure. Key Responsibilities: Identify/manage regulatory risks (GxP, cGMP, FDA, 21 CFR Part 11) Author validation strategies, protocols, and reports (end-to-end CSV required) Execute IQ, OQ, PQ in compliance with cGMP Work with cross-functional teams: R&D, QA, IT, Manufacturing, Engineering Validate systems in Agile SDLC environments Review validation lifecycle documentation Support Change ...

As a Sr. Validation Engineer at CMIC CMO USA Corporation in Cranbury, NJ, your role involves utilizing pharmaceutical science analytics to author validation protocols in compliance with cGMP/FDA standards. You will be responsible for planning, managing, and executing start-up, commissioning, and validation of new pharmaceutical equipment. Additionally, you will draft and implement qualification protocols, resolve deviations and CAPA, prepare validation reports, develop SOPs for manufacturing and packaging equipment, as well as write test protocols. **Key Responsibilities:** - Author validation protocols in compliance with cGMP/FDA standards - Plan, manage, and execute start-up, commissioning...

Responsibilities: Ensure compliance with regulatory requirements through CSV processes. Implement LIMS, Labware Lims & DMS systems. Conduct CSV activities for equipment validation. Health insurance Annual bonus Provident fund Flexi working

Educational Requirements Master of Pharmacy,Master Of Technology,Bachelor of Pharmacy (Honors),Bachelor Of Science,Bachelor of Engineering,Bachelor Of Technology Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS...

About The Role Project Role : Software Development Lead Project Role Description : Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills : Veeva Vault Good to have skills : NA Minimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Veeva Safety Application Development SME, 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 ...

About The Role Project Role : Software Development Lead Project Role Description : Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills : Veeva Vault Good to have skills : NA Minimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Veeva Application Development SME, 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 ...

To maintain GLP & GDP in lab. Perform literature searches for new products. To guide method validation activity & troubleshoot problems. Monitor IQ,OQ & PQ activity. Review analytical data. Preparation of Method Validation protocol & report.

Role Overview: As an Electrician Diploma at Surmount Laboratories Pvt. Ltd., you are expected to have a minimum of 2 to 5 years of experience with a strong understanding of HU DY System Knowledge. Your responsibilities will include pre-balancing, filter cleaning work, documentation work, as well as knowledge in IQ, OQ, PQ, DQ HVAC Qualification. Key Responsibilities: - Perform pre-balancing and filter cleaning work - Handle documentation tasks efficiently - Demonstrate knowledge in IQ, OQ, PQ, DQ HVAC Qualification - Maintain preventive maintenance documentation - Manage general documents related to the field Qualifications Required: - Diploma in Electrician - Minimum 2 to 5 years of relevan...

As a Manufacturing Engineer at this company, your primary role is to execute Manufacturing Engineering activities focusing on high-quality Process Verification & Validation. Your responsibilities include sustaining and improving processes, tools, and equipment of the Manufacturing systems to ensure predictable, reliable, stable, and efficient production processes. You will also support troubleshooting activities, new product industrialization projects, and manufacturing transfers for the site. Key Responsibilities: - Drive meaningful and innovative Process Validation - Suggest improvements in the process to enhance quality and reduce costs - Support Process Verification, Validation, IQ, OQ, ...

Position Overview: We are seeking a knowledgeable and results-driven CSV Engineer to join our team, specializing in providing expert validation services to our clients. In this role, you will work closely with a diverse range of companies, ensuring the compliance, reliability, and quality of their computerized systems while adhering to industry regulations and best practices. Key Responsibilities: Validation Strategy and Planning: - Collaborate with clients to develop tailored validation strategies and plans based on their specific needs and regulatory requirements. - Assess project scope, goals, and timelines to design efficient validation approaches. Validation Execution: - Design, develop...

Responsible for implementation, and effectiveness of Validation strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, compliance related activities (ICH, 21 CFR, GPDR etc), and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 r...

Day-to-day design and documentation activities (i.e. Validation Documents, DQ, IQ, OQ, Operating Instruction Manual etc. AutoCAD 2D Drawing (GA Drawing, Layouts, Part Drawing) Measuring Instruments & Basic Knowledge of Standard Mechanical Components.

Quality Assurance Compliance Specialist Location: Pune-Hybrid working-Twice a week in the office Status: Permanent, Full Time Package: Competitive Salary (fixed), 5 Day Working Week, Flexible Working (with one-off allowance), Development & Opportunity (Personal & Technical), Group Medical Policy, Group OPD Cover, Personal Accident Cover, Term Life Cover, 26 Days Leave + 9 Public Holidays + Buy & Sell Scheme, Referral Scheme. Why are we hiring a Quality Assurance Compliance Specialist? Were on the hunt for a Quality Assurance Compliance Specialist as part of our company’s growth. The Quality Assurance Compliance Specialist provides day-to-day support for Quality Assurance and Information Secu...

As an experienced professional with 3-4 years of overall experience, you will be responsible for a variety of tasks in the manufacturing industry in Pune. Your role will involve the following key responsibilities: - Good in documentation, particularly in regulated industries like Medical device, Pharma, and Aerospace. Your experience in authoring documents and working with GDP will be highly beneficial. - Proficiency in statistics to support various activities within the manufacturing process. - Effective communication skills to facilitate discussions, especially in handling manufacturing activities. - Hands-on mentality to perform activities related to PV, such as TMV, IQ, OQ, and PQ. Exper...

Work Flexibility: Hybrid What you will do: Support the implementation of process improvements to Corporate/Site/Division Supplier Initiated Change Request procedures and process. Served as owner, execute, and maintain the electronic systems related to SICRs, and support data alignment (SICR Database & OnePLM SICR Library) Challenge suppliers SICRs forms for completeness and accuracy. Discuss corrections to the form to guarantee a smooth assignment and execution of the change. Own & Execute Supplier Initiated change request (SICR) submitted by Global Suppliers Review Submitted SICRs and challenge suppliers for missing information & required deliverables for approving the change Organize SCRB ...

Capgemini Invent Capgemini Invent is the digital innovation, consulting and transformation brand of the Capgemini Group, a global business line that combines market leading expertise in strategy, technology, data science and creative design, to help CxOs envision and build whats next for their businesses. Your Role Use Design thinking and a consultative approach to conceive cutting edge technology solutions for business problems, mining core Insights as a service model Engage with project activities across the Information lifecycle. Understanding client requirements, develop data analytics strategy and solution that meets client requirements Apply knowledge and explain the benefits to organi...

Preparation of documents such as IQ, OQ, DQ Job Description- (Incumbent needs to do/ Needs to know/ Outcome anticipated) Preparation of Project documents such as IQ, OQ, DQ as per requirement Incumbent needs to know - Basics of documents such as IQ, OQ, DQ - Excel, Word Experience Handling documentation activities for Minimum 6 months, preferably for WT projects in pharma.

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and...

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview TE Connectivity's Manufacturing and Process Development Engineering Teams significantly impact LEANPD driven new product development projects, driving for excellence in existing manufacturing technologies and methods and striving to implement new manufacturing technologies to provide improved process and tolerance control. They act as the binding element between product development and manufacturing engineering, ensuring the effectiveness and efficiency of this critical interface. They support Product Development in the optim...

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and...

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. Job Description Roles and Responsibilities Establish and execute project quality plan, witness-points, quality records for compliance with contract. Ensure customer quality requirement, Feedback of Experience (FOE)/Lessons Learned are taken into account to avoid deviat...

Responsible for documentation verification, FAT/SAT support, and ensuring accuracy in machine records. Requires IQ/OQ/DQ knowledge, AutoCAD, MS Office, and basic automation, electrical & pneumatics understanding. Required Candidate profile B.E/Diploma in Mechanical/E.C./IC with expertise in AutoCAD, MS Office & technical docs. Skilled in packaging machine docs, IQ/OQ/DQ, automation & pneumatics; precise, detail-driven communicator.

You will be responsible for equipment validation and Quality Management System (QMS) related activities. Your main duties will include the preparation, review, execution, and compilation of validation protocols for in-house Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of all equipment and systems used in Injectable production at the Indore site. Additionally, you will ensure that Periodic Performance Verification (PPV) is conducted and approved according to the PPV schedule. As part of your role, you will be required to manage a team and allocate tasks effectively. You will also oversee the QMS system, including handling change control, ...