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5.0 - 10.0 years
5 - 9 Lacs
bengaluru
Work from Office
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
Posted 2 months ago
3.0 - 6.0 years
10 - 15 Lacs
hyderabad
Hybrid
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 ...
Posted 2 months ago
4.0 - 6.0 years
4 - 5 Lacs
mumbai
Work from Office
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
Posted 2 months ago
20.0 - 24.0 years
0 Lacs
pune, maharashtra
On-site
Role Overview: You will be responsible for leading a team of Team Leads, engineers, and designers to guide and support in various stages of automotive interior/exterior trims and seating system components. Your role will involve concept design, engineering feasibility, validation, production build, launch, and post-launch support to ensure project milestones are met. Key Responsibilities: - Lead and guide the team in achieving project milestones for components and assemblies, including make and buy discussions, cost, weight, and quality balancing. - Manage design detailing, release activities, validation plan, tooling feasibility, tooling evaluation, initial quality check, and tool sign-off ...
Posted 2 months ago
5.0 - 10.0 years
8 - 12 Lacs
pune
Work from Office
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...
Posted 2 months ago
6.0 - 8.0 years
1 - 5 Lacs
hyderabad
Work from Office
Review, Validation IQ, PQ, IQ13 document as needed and amend validation documentation with IT requirements. Provisioning the PC according to Lead Lab Guidelines Request for access to a system, application H/w, S/W, Database
Posted 2 months ago
8.0 - 12.0 years
8 - 10 Lacs
ankleshwar
Work from Office
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.
Posted 2 months ago
2.0 - 6.0 years
0 Lacs
maharashtra
On-site
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...
Posted 2 months ago
4.0 - 8.0 years
0 Lacs
pune, maharashtra
On-site
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, ...
Posted 2 months ago
1.0 - 5.0 years
3 - 6 Lacs
ahmedabad
Work from Office
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...
Posted 2 months ago
2.0 - 4.0 years
3 - 5 Lacs
ahmedabad
Work from Office
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.
Posted 3 months ago
5.0 - 10.0 years
4 - 8 Lacs
pune
Work from Office
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...
Posted 3 months ago
3.0 - 8.0 years
11 - 16 Lacs
gurugram
Hybrid
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 ...
Posted 3 months ago
3.0 - 5.0 years
3 - 5 Lacs
bhilwara
Work from Office
Role & responsibilities Key Responsibilities: A.) Software Application Rollout of P2P automation (developed by vendor) including Vendor Registration, PR, RFQ, PQ, CS, NFA, ASN, SRN, Service Entry Sheet, RGP, NRGP, and DC generation. Manage licenses (Premium, Team Member, Device-based) and assign as per user activity. Oversee cloud updates, AMC support, and partner managed services . Maintain roles, permissions, and workflows as per Segregation of Duties (SOD) and MakerChecker concept. Ensure Sandbox UAT testing before Go-Live for automation/customizations. Perform monthly & yearly closure activities in Business Central. Ensure efficient Business Central storage utilization by implementing Ch...
Posted 3 months ago
4.0 - 9.0 years
12 - 16 Lacs
pune
Work from Office
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...
Posted 3 months ago
1.0 - 5.0 years
4 - 5 Lacs
mumbai, navi mumbai
Work from Office
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.
Posted 3 months ago
5.0 - 10.0 years
7 - 12 Lacs
bengaluru
Work from Office
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...
Posted 3 months ago
5.0 - 10.0 years
7 - 12 Lacs
bengaluru
Work from Office
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...
Posted 3 months ago
3.0 - 7.0 years
0 Lacs
indore, madhya pradesh
On-site
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, ...
Posted 3 months ago
10.0 - 14.0 years
0 Lacs
mumbai, maharashtra, india
On-site
Job Description Business: Piramal Critical Care Department: Information Technology Location: Kurla Travel: Low Job Overview To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites. Key Stakeholders: Internal Business Site / Central Partner functions IT Team (e.g. SAP / Infra / Quality IT / Allied / SAP etc) Key Stakeholders: External IT Vendors, IT Contractors/Consultants, Piramal CSV Partner Reporting Structure Reports to: AGM IT - CSV Education Qualification & Experience Graduate in Science/Pharmacy/Engineering Post Graduation MPharm/Science/MBA (Desirable) Candidate with 10-14 years of e...
Posted 3 months ago
3.0 - 6.0 years
4 - 8 Lacs
gurugram
Work from Office
About the role The SRM will ensure that business stakeholders manage suppliers in line with risk appetite, optimising post-contract value, and developing a transparently sustainable supply base. The role holder will collaborate closely with senior stakeholders from across FIL to establish broad internal stakeholder relationships, drive value from, and manage risk across the supplier portfolio. These stakeholders include but are not limited to: senior executives across FIL; Supplier Relationship Managers (SRMs) across FIL; Supplier Risk Oversight (Procurement 2LoD function); Senior Procurement Category leaders; and risk partners across FIL. The SRM will be use experience of supplier risk and ...
Posted 3 months ago
12.0 - 15.0 years
11 - 15 Lacs
bengaluru
Work from Office
About The Role Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : Computer System Validation (CSV) Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will engage in the analysis and design of innovative business processes. ...
Posted 3 months ago
15.0 - 25.0 years
11 - 15 Lacs
bengaluru
Work from Office
About The Role Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : Computer System Validation (CSV) Good to have skills : NAMinimum 15 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will engage in the analysis and design of innovative business processes. ...
Posted 3 months ago
3.0 - 7.0 years
4 - 9 Lacs
bengaluru
Work from Office
About The Role We are seeking a skilled and experienced MES Engineer with hands-on expertise inKrber Werum PAS-Xto support manufacturing operations in a regulated pharmaceutical or life sciences environment. The ideal candidate will have a strong technical foundation, validation knowledge, and excellent communication skills to effectively bridge the gap between technical teams and business stakeholders. Key Responsibilities:- MBR Design & Development: Design and create complex Master Batch Records (MBRs) for Weighing & Dispensing, Manufacturing, and Packaging processes. Analyze site-specific requirements and translate them into functional MBRs. Validate MBRs for deployment across manufacturi...
Posted 3 months ago
4.0 - 9.0 years
10 - 15 Lacs
ahmedabad
Work from Office
Deloitte is looking for Deputy Manager | CSV | | SAP to join our dynamic team and embark on a rewarding career journey Assist the Manager in the day-to-day operations of the business, including setting goals, developing strategies, and overseeing the work of team members Take on leadership responsibilities as needed, including managing team members and making decisions in the absence of the Manager Identify and address problems or challenges within the business, and develop and implement solutions Collaborate with other departments and teams to ensure smooth and efficient operations Maintain accurate records and documentation Contribute to the development and implementation of business plans...
Posted 3 months ago
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