415 Gxp Jobs - Page 7

We are hiring for for CSV IT Location : Ahmedabad Corporate Office Designation : Sr Executive Candidate should have Computer System Validation expertise in below systems: Enterprise Application GxP Applications Computer System Validation. Laboratory Instrument software/ Control Systems. Mfg. Control Systems Mfg. Equipment / PLC/SCADA SDLC SAP Preparation and review of Validation (Strategy) Plans, User Requirement Specifications. Preparation and Review of Functional Specifications S/W Design Specifications or Configuration Documents. Preparation of computer system validation documents. Traceability Matrix, Risk Analysis. Validation Reports, Change Controls/Deviations etc. IT Compliance: Works...

About the job Company Context Sanofi's strategic direction is to standardize processes across sites, embrace digital transformation of its Manufacturing & Supply perimeter, simplify its current solution landscape, and leverage advanced technologies to bring business value. The MARS (MES Accelerated Roadmap @ Sanofi) program aims to implement Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). This program will transform Sanofi plants, improving compliance, cost, and cycle time performance. Over recent years, Sanofi has deployed various Production sites across GBUs (multiple pharmaceutical processes, Weighing & Dispensing & fu...

About the Job Company Context Sanofi's strategic direction is to standardize processes across sites, embrace digital transformation of its Manufacturing & Supply perimeter, simplify its current solution landscape, and leverage advanced technologies to bring business value. The MARS (MES Accelerated Roadmap @ Sanofi) program aims to implement Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). This program will transform Sanofi plants, improving compliance, cost, and cycle time performance. Over recent years, Sanofi has deployed various Production sites across GBUs (multiple pharmaceutical processes, Weighing & Dispensing & fu...

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

Role Overview The MBR Developer is responsible for building, testing, and implementing Master Batch Records (MBRs) and related components within the Manufacturing Execution System (MES). You will ensure that MBR configurations align with the Core model and operational excellence standards while adhering to Sanofi Digital and Industrial standards for Processes, Applications, and Infrastructure environments. Working in close collaboration with MES Digital Product Configuration Manager, MES Digital Product Configuration Experts, MES Product Owner, MES installers/developers, Product lines, local digital teams, Business Process Owners, and Site modelers, you will contribute to the successful impl...

Job Summary: The MES Lifecycle Manager drives the strategic planning and execution of MES installations, updates and migrations across Sanofi's industrial network and the lifecycle planning in alignment with the Product Owner Vision & product Roadmap. This role provides technical and strategic leadership in developing and implementing long-term strategies to optimize MES performance, reduce obsolescence, and align MES capabilities with Sanofi's digital transformation goals. Main Responsibilities: Strategic MES Lifecycle Management: Develop and execute a comprehensive MES lifecycle planning/ strategy aligned with Sanofi's digital transformation objectives, Product Owner Vision & product Roadm...

Role Overview: The MES DevOps Manager is responsible for leading the delivery, design/ build/ implementation and continuous enhancement of global end-to-end Manufacturing Execution System (MES) solutions at Sanofi. This role focuses on team mgt/leadership, technical mgt/expertise, and delivery excellence to ensure MES configurations meet the needs of Sanofi's manufacturing operations while adhering to quality, regulatory, and cybersecurity requirements. The manager will manage a team (functionally, technically and administratively)of MES DevOps Engineers and MBR developers, take the ownership/ leadership of technical delivery of the team to answer to the requirements of manufacturing sites a...

About the Job Job Summary The MES Reliability Engineer ensures the stability and performance of Manufacturing Execution Systems (MES) to maximize operational value. This role serves as a bridge between development and operations teams, taking a proactive approach to prevent downtime, optimize system performance, and ensure the reliable operation of manufacturing systems that are critical to production. Main Responsibilities Incident Management and Resolution Anticipate, Prevent and Lead incident response efforts to swiftly resolve MES service disruptions, minimizing impact on manufacturing operations Conduct thorough analyses of system failures and implement preventive measures to avoid futu...

Immediate joiner - Coordinate instrument & equipment qualification and preparation of SOP. Provide application support for GxP system and software administrator. Execute user management, data backup & restoration activities administrator.

Seeking LIMS Developer with 3–7 years experience in Labware LIMS configuration, customization, deployment, and support. Pharma/Life Sciences background required. Strong SQL, Java, and JBoss skills essential.

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

Role Overview: You will be responsible for ensuring the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting. Additionally, you will assist in Health Authority inspections and internal audits by supplying information and documentation in a timely manner. You will support and track the implementation and maintenance of the local Quality system in accordance with the Sandoz Quality Manual. Moreover, you will manage processes and systems for all GxP Quality Assurance including Change control, Training Management, Escalation Management, and Risk Management. It is essential to ensure that all processes are conducted in full compliance ...

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...

'Experienced Snowflake and Data Visualization developer - Proficient analytics developer with technical skills with Snowflake and visulization tools with TIBCO Spotfire. This candidate has technical expertise in in data analysis, reporting, and dashboard development, Supporting the build and standardization of EHS reporting eco-system. - Develop at scale industrialized data science visualization capabilities and analytic products - Create visualization products and templates in the delivery of analytic insights products - Data visualization expert in TIBCO Spotfire (required) with solid understanding in data modeling with Snowflake Technical background, analytical skills, understanding of da...

Role & responsibilities Experienced Data Warehouse Developer/DBA with expertise in building data pipelines, curating data, modeling data for analytics, and providing subject matter expertise with experience implementing end-to-end data warehouse/data lake solutions including ETL development, data profiling, data curation, data modeling and deployment with expertice in Postgres, Reddit, Redis, C#, Python. - Expert in Databases creating, governance and ETL development. - Expert in Postgres, Reddit, Redis, C#, Python - Proven track record of data warehouse/data lake data development including building data pipelines and data modeling. - Strong experience in SQL, data curation, ETL tooling and p...

Develop and implement the company’s IT strategy, aligning with business goals. Oversee the IT infrastructure, including networks, databases, and software systems. Ensure data security and compliance with relevant data protection regulations.

Create and lead solution designs for internal customers and help scoping of requirements to meet business needs. Develop project rationale and perform scoping assessments to determine feasibility of projects Will be required to interact with various stakeholders at the business functional level and provide assistance on any infrastructure-related issues in collaboration with teams. Understand the business requirements, design and deliver end-to-end infrastructure solutions as per Novartis Infrastructure standards Proficiency on AWS services like EC2, VPC, S3, RDS, Lambda, CloudFront, EBS, EFS, ASG, IAM, ELB, Data sync, Route53, EKS, ECS etc., Ensure overall user experience is taken into acco...

As a CSV (Computer System Validation) Consultant/ Lead your responsibilities includes developing validation plans, protocols, and test scripts; executing tests; performing risk assessments; documenting all processes; and ensuring that systems adhere to regulatory requirements throughout the lifecycle. Required Skills and Qualifications Technical Skills: Proficiency with validation software (e.g., MS Project, ALM, Veeva Vault) and an understanding of manufacturing and supply chain applications. Regulatory Knowledge: Strong understanding of GxP, FDA regulations, and other relevant industry standards. Analytical and Problem-Solving Skills: Ability to assess systems for quality and compliance, a...

Role Overview: As a Quality Operations Support at Sandoz, your primary responsibility is to ensure compliance with current GxP and regulatory requirements while delivering quality operations to maintain product quality compliance and regulatory workflows. Your role involves upholding Sandoz quality standards, relevant regulatory requirements, filed product quality standards, and service level agreements. Additionally, you will play a key role in supporting the implementation of service quality and process improvement projects, as well as managing CAPA within GQSI. It is vital to adhere to internal functional requirements, including KPI reporting, ticket management tools, and other internal p...

Role Overview: As a Computer System Validation (CSV) Engineer specializing in SAP HANA/S/4HANA validation at a prestigious MNC Pharma company in Mumbai, your primary responsibility will be to develop and oversee CSV deliverables, including VP, URS, FRA, IQ/OQ/PQ, etc. It is crucial to ensure compliance with regulatory standards such as 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaboration with various teams such as QA, IT, and BPOs will be a vital aspect of your role. Additionally, you will be involved in managing SAP system upgrades, patches, and audits as part of your daily tasks. Key Responsibilities: - Develop and oversee CSV deliverables like VP, URS, FRA, IQ/OQ/PQ, etc. - Ensure compl...

7–10 years of experience in CSV with a focus on SAP implementation in a GxP-regulated industry and knowledge of GxP guidelines, M.Sc. in IT / B. Tech in Computer Science or equivalent will be preferred.

1. Understanding of various SDLC methodologies (Agile, Waterfall, V) 2. Experience in Programming or scripting languages (Java/JS etc.,). 3. Experience in designing automation frameworks (POM, Cucumber BDD, etc.,). 4. Generate Automation Test Strategy for applications deployed on Cloud. (Public and Private cloud) 5. Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. 6. Working experience in testing Restful Webservices and APIs using frameworks or tools like POSTMAN, Rest API, etc. 7. Good experience with VAPT. 8. Knowledge of Performance testing using Jmeter or any open-source tools. 9. Perform Risk Analysis of Project & automation...

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...

GxP, GLP, regulatory environments Support Analyst Role: Support Analyst / Application Administrator We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applications supporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validat...

Have sound knowledge and experience in CSV in pharma. Understand FRA , Execute OQ's Create and maintain validation documents like Operational qualification, Test Reports Knowledge of Regulations and guidelines like 21 CFR part 11, EU annex 11, GDPR Strong analytical and problem-solving skills. Ability to work as part of team. Experience in Automation and Test Management tool Call me 9701923036 or mail :gopi.c@acesoftlabs.com