231 Gxp Jobs - Page 7

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. Your role 1. Experience of agile methodologies such as Scrum, Kanban, etc and knowledge of scaled frameworks like SAFe etc. 2. Experience in tracking and publishing different metrics regularly to various stakeholders like Sprint reports, Status,...

Title : GXP Validation Testing | 4 to 18 years | Mumbai, Pune, Hyderabad & Bengaluru Design, develop, and execute test cases, test scripts, and test plans based on project requirements. Conduct functional, regression, integration, and acceptance testing. Track and document defects, issues, and ensure timely resolution. Collaborate with cross-functional teams to understand requirements and provide feedback on system designs. Ensure all manual testing activities are documented according to company policies and standards. Apply GXP testing practices (Good Laboratory Practices, Good Manufacturing Practices, Good Clinical Practices) to ensure software meets regulatory compliance and industry stan...

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ About the Role: ValGenesis is looking for a passionate and experienced Product Management to join our rapidly growing team. In this role, you will help define the product strategy and roadmap for our product lines. ...

Role & responsibilities To lead and manage the Computer System Validation (CSV) activities for our injectable manufacturing operations. The candidate need to ensure compliance with regulatory requirements (e.g., US FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and internal quality standards for all GxP-relevant computerized systems used across production, quality control, and laboratory environments. Lead and oversee all CSV activities for GxP-critical systems (LIMS, ERP, MES, SCADA, PLCs, EMS, BMS, etc.) in the injectable manufacturing setup. Develop and maintain validation master plans (VMPs), risk assessments, validation protocols (IQ/OQ/PQ), and reports in line with regulatory expectations an...

Roles and Responsibilities : Develop and maintain GXP (Good X Practices) documentation for pharmaceutical processes, ensuring compliance with regulatory requirements. Collaborate with cross-functional teams to identify areas for improvement in CSV (Commercial Specifications) and implement changes as needed. Conduct audits of manufacturing facilities to ensure adherence to cGMP guidelines, identifying non-conformities and implementing corrective actions. Provide training on GAMP (Good Automated Manufacturing Practice) principles to production staff. Job Requirements : 1.5-5 years of experience in a pharmaceutical or life sciences industry setting. Strong understanding of GXP, CSV, gGMP, and G...

Labware LIMS Functional consultant with experience in Labware LIMS, Labware ELN, Labware Mobile, LIMS V7, Implementation, rollouts, GXP, FDA, ISO,

Role & responsibilities Experience in Authoring all CSV deliverables e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. as per V Model for IT projects Experience on validation of any of the enterprise level applications. e.g. Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes. A team player with good communication skills (verbal & written) Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, GAMP 5 (Must) Good knowledge of Data Integrity requirements for Pharma...

Project Role : Security Delivery Lead Project Role Description : Leads the implementation and delivery of Security Services projects, leveraging our global delivery capability (method, tools, training, assets). Must have skills : Cloud Security Architecture Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Security Delivery Lead, you will lead the implementation and delivery of Security Services projects, leveraging our global delivery capability (method, tools, training, assets).We have a requirement for an AWS Cloud Security Engineer to join our growing cloud security team within a leading global pha...

What you will do In this vital role you will take ownership of Transportation Master data processes, ensuring the accuracy, consistency, and governance of critical data across the organization. This role will lead data validation, cleansing, and enrichment efforts, and collaborate with cross-functional teams to resolve complex data issues and drive process improvements. The Transportation Master Team Lead will also oversee key performance metrics, ensure compliance with data governance standards, and lead data migration and integration initiatives. Roles & Responsibilities: Lead and manage day-to-day MDM operations, including data validation, cleansing, and enrichment processes Oversee data ...

Req ID: 324406 We are currently seeking a Systems Integration Advisor to join our team in Noida, Uttar Pradesh (IN-UP), India (IN). Position Summary: Performs IT functions such as design, analysis, evaluation, testing, installation, acquisition, modification and support of operating systems, database, or software. Plans, conducts, and directs the analysis of business problems to be solved with troubleshooting and automated systems. This position operates with minimal direction and requires a professional who can take ownership over their work. This position is in support of the Core Services team in Corporate IT at Enlyte. Core Services includes the management of Active Directory, Microsoft ...

Req ID: 324412 We are currently seeking a Systems Integration Advisor to join our team in Noida, Uttar Pradesh (IN-UP), India (IN). Position Summary: Performs IT functions such as design, analysis, evaluation, testing, installation, acquisition, modification and support of operating systems, database, or software. Plans, conducts, and directs the analysis of business problems to be solved with troubleshooting and automated systems. This position operates with minimal direction and requires a professional who can take ownership over their work. This position is in support of the Core Services team in Corporate IT at Enlyte. Core Services includes the management of Active Directory, Microsoft ...

Eligibility Relevant Experience : 7 -15 Years, Notice Period: 0 -30 days Locations: Hyderabad/Bangalore/Chennai/Pune/Mumbai/New Delhi Work Mode: Work From Office/Hybrid Job Description Minimum 2-3 End to End Green Field Implementations on SAP SCM(s/4HANA) Essential Skills and Experience Experienced SAP Supply Chain consultant with exposure to PPDS and how the two products are used in conjunction with required master data. Previous experience in triaging SAP incidents, and liaising with end users to identify and resolve issues. Good communication skills including liaison with various stakeholders via video calls and Emails. Experience of working in regulated environments (e.g. pharmaceutical)...

Minimum 8 years of exp in OSI-PI. Excellent understanding of the OSI PI system architecture Primarily an Individual contributor and responsible for a small team. Main scope of work is to provide solution architecture, support business, making sure applications are well-designed and conform to Merck standards. Actively drives the installation, implementation in projects and supports solutions of new technologies and opportunities to optimize technology/IT systems. Hands on experience in configuring/ designing solutions based on OSI PI (Now Aveva). Hands on experience in standard products like OPC UA, OPC DA / HDA etc. Hands on experience in PI Visualization Suite - PI DataLink, PI ProcessBook...

Greetings for day. We are having opening for the role Manager - QMS & Documentation Management in Corporate Quality Department. Department : Corporate Quality Location : Mumbai - Andheri East Qualification - B. Pharm. / M. Pharm / M. Sc. Industry Preferred : Pharmaceutical. Work Experience :12 - 18 years Corporate Experience only. Job Description : Quality Management System (QMS) Oversight: Ensure robust implementation and periodic / Retrospective review of all QMS elements including Change Control, Deviation, CAPA, Risk Management, and Quality Review. Documentation Lifecycle Management: Coordinate periodic SOP revision cycles. Ensure alignment with current practices, regulations, and audit ...

The SuccessFactors Administrator will contribute to the administration of our SuccessFactors installation and serve as a System Administrator and resource for our rapidly growing team. This includes deployment activities, configuration, installation, and ongoing improvements on the platform. The individual in this role will work closely with other IT teams, business and functional leaders, and subject matter experts to ensure all project activities are performed to a high degree of quality, meets practice and standards expectations, and ensures delivery in a timely fashion. A blend of technical and problem-solving skills and value-to-business mindset would be an advantage for this role. Esse...

Experience:- 2+ Years. Location:- Electronic City, Bengaluru. Skills:- Authorising, Reviewing, Validation Documents Minimum Qualifications expected for the candidates • Degree in computer engineering / equivalent. with CSV especially in IT pharma enterprise systems • Strong communication skills • A comprehensive understanding of GxP, GAMP 5, Infrastructure Management, Computerized System Validation, (Initial Risk Assessment, Disaster Recovery Process, Data Security etc), and QMS. • Proficiency in project and stakeholder management

Role: System Administrator Department: IT Location: Bidar About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opport...

Information Security GxP Specialist What you will do Let’s do this. Let’s change the world. In this lead role you will support the GRC Governance / Policy & Audit team working closely with Technology teams to help ensure that GxP controls are in place, GxP deviations are managed and monitored, and security standards are met. The GxP Specialist will assist in owning and maintaining GxP deviation records, performing GxP assessments, managing controlled documents, and supporting regulatory compliance efforts. Roles & Responsibilities: GxP Governance Leadership: Support the GRC organization in leading a team of GxP and/or policy analysts performing tasks related to governance, GxP deviation mana...

About The Role Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgen’s Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, help...

Let’s do this. Let’s change the world. In this vital role you will serve as a Technology supervising the delivery of enhancements and integrations for Medical Information Websites. You will handle full lifecycle project execution — from planning through delivery — while ensuring alignment with global product strategy, GxP/CSV requirements, cybersecurity standards, and Amgen’s governance model. This role also requires close coordination across functional and technical teams, including business collaborators, Salesforce development teams, product analysts, QA/validation, and global platform teams. You will also serve as a liaison between onsite and offshore teams, ensuring seamless collaborati...

Job Information Job Opening ID ZR_1871_JOB Date Opened 14/04/2023 Industry Technology Job Type Work Experience 8-12 years Job Title Architect City Bangalore Province Karnataka Country India Postal Code 560048 Number of Positions 1 Minimum 8 years of exp in OSI-PI. Excellent understanding of the OSI PI system architecture Primarily an Individual contributor and responsible for a small team. Main scope of work is to provide solution architecture, support business, making sure applications are well-designed and conform to Merck standards. Actively drives the installation, implementation in projects and supports solutions of new technologies and opportunities to optimize technology/IT systems. H...

Dear Candidate Hope you are doing well My name is Bhavani, I am a recruiter from Yallas Technology solutions We are Hiring a job opportunities. please find the position details below. Title: Computer System Validation (CSV) Expert( SAP CSV) Duration: Permanent Position Location: Hybrid/work from home(if client asked, need to work at client location) Notice period- Immediate - 7 days Job Description: You have successfully completed studies in the field of computer science, engineering or a related field. • You are passionate about ensuring compliance and quality in software solutions tailored for the life sciences industry. • You have minimum of 5 years proven experience in the field of CSV /...

Job Role: CQV Engineer Experience: 2-4 years Location: Bengaluru Key Responsibilities: Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc. Participate and coordination with engineering & OEMS for FAT/SAT. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM. Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment. Perform Qualification as per the regulatory requirements (e.g., FDA, WHO) Should have sound knowledge in good documentation Pr...

BDM: CSV/GxP Consultancy Sales *Hunt new clients (Pharma/Biotech/Med Device). Deep CSV/GxP knowledge (3+ yrs sales req). Build relationships, close deals. Travel 50-60%. Competitive base + uncapped commission. Impact patient safety.*

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collabo...