418 Gxp Jobs - Page 13

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Manufacturing Engineering MES Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, 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 that application development aligns with business objectives, overseeing project timelines, and facilitating communication among stakeholders to dr...

Perform manual testing of applications in GxP-regulated environments (GMP, GLP, GCP). Review and understand User Requirements Specifications (URS) and Functional Specifications (FS) . Design and execute test cases , test scripts , and test data based on regulatory and business requirements. Ensure all testing activities comply with 21 CFR Part 11 , Annex 11 , and ALCOA+ principles. Maintain comprehensive test documentation , including traceability matrices , test summary reports , and deviation logs . Participate in validation activities including IQ, OQ, and PQ phases. Collaborate with QA, business analysts, and development teams to ensure audit readiness . Support internal and external aud...

Role & responsibilities Strategic Responsibilities: Define and govern the corporate CSV strategy across all units/sites for GxP systems, including SAP HANA. Lead enterprise-wide validation projects ensuring alignment with GAMP 5 , 21 CFR Part 11 , EU Annex 11 , and global data integrity expectations. Establish and monitor corporate SOPs, templates, and risk-based approaches for computer system validation. SAP HANA Specific Responsibilities: Lead validation of SAP S/4HANA (MM, QM, PP, and Z-reports, workflows, GRN process) across GxP operations. Prepare and maintain validation documentation including URS, Functional Specs, Test Scripts (IQ/OQ/PQ), RTM, and final reports for SAP HANA modules. ...

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 applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system fu...

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 applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeho...

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 applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system fu...

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 applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system fu...

(A) RESPONSIBILITIES : 1.) PROJECTS: Budgeting, Technical Detailing, Planning & Execution for Dahej Plant. Design, Coordinate and implement the systems, as per the standards defined for Dahej. Capex & Revenue Budget preparation for Dahej plant. Monitoring End User's support at Dahej Plant. Review all assets (physical and records) on a regular basis. Ensure records of analytical Systems connected to Analytical servers are also kept up to date on a regular basis. Handling of Infrastructure Maintenance, IT Consumables, repairs & Inventory at Dahej Location. 2.) GMP/GLP COMPLIANCE: Prepare and maintain compliance document for production and QC production equipment / system. Prepare SOP, Protocol...

Dear Candidate, Greetings of the day! We are hiring for the position of Cluster Head IT (GM) for Aurangabad location. Company Profile: Harman Finochem Limited leading India-based pharmaceutical company which was established by Late Mr. Bhupinder Singh Manhas in 1983. It specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APIs) of which 10 are Essential drugs as per the WHO model list. Company has its Head office at Kalina, Santacruz (East), Mumbai and 3 state-of-the-art API manufacturing facilities and one formulation manufacturing site at Aurangabad that have been inspected by USFDA. Role & responsibilities : Establishing organizational technology vi...

About the Role: Grade Level (for internal use): 08 The Role Implementation Engineer The Team The Portfolio Analytics (PA) Application Support team is responsible for onboarding and supporting clients on the Capital IQ platform. Historically focused on manual ingestion workflows and reactive troubleshooting, the team is now evolving to take on a more technical, proactive, and scalable approach. This role will be key in driving that transformation building automation, scripting ingestion processes, and supporting API-based integrations. The Impact This is not just another support role. You will be part of the teams next chapter helping shift from manual operations to automated, scalable soluti...

Cloud Architect with 5-10 yrs exp. in Azure AD IAM, PIM/JiT, IaC (Bicep/Terraform), and cloud security. Lead IAM design, optimize AAD, integrate DevOps, ensure compliance, support teams, and stay ahead of trends. Pharma/GxP & SAFe a plus.

Expertise in computer system validation, QMS and IT Compliance. Good understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9. QMS: Initiation/Review of change management, Investigation, CAPA, Deviation etc. WFO, Mumbai - Immediate - 15 Days

Hi, Wishes from GSN!!! Pleasure connecting with you!!! We been into Corporate Search Services for Identifying & Bringing in Stellar Talented Professionals for our reputed IT / Non-IT clients in India. We have been successfully providing results to various potential needs of our clients for the last 20 years. At present, GSN is hiring Business Analyst - LIFE SCIENCE for one of our leading MNC client. PFB the details for your better understanding : 1. WORK LOCATION : Chennai 2. Job Role: Business Analyst 3. EXPERIENCE : 7 to 15 yrs 4. CTC Range: Rs. 15 to Rs. 25 LPA 5. Work Type : WFO ****** Looking for SHORT JOINERS ****** Job Description : 7+ years of relevant experience in Business Analysis...

Context Sanofi strategic direction is to standardize processes across sites, to embrace the digital transformation of its Manufacturing & Supply perimeter, looking at the opportunity to simplify its current solution landscape and leverage advanced technologies to bring business value In that context, the MARS program aims to implement the Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES) The MARS (MES Accelerated Roadmap @ Sanofi) program will transform Sanofi plants, improving compliance, cost and cycle time performance Over the last 3 years, Sanofi has deployed 30 Production sites across 4 GBUs (multiple and different phar...

We are looking for a highly skilled and experienced professional to join our team as a Manager - Sample Collection at Vijaya Diagnostic Centre. The ideal candidate will have a strong background in healthcare, with excellent leadership and management skills. Roles and Responsibility Manage and supervise the sample collection team for efficient operations. Develop and implement effective strategies for improving sample quality and reducing errors. Collaborate with other departments to ensure seamless communication and coordination. Analyze data and metrics to identify areas for improvement and optimize processes. Ensure compliance with regulatory requirements and industry standards. Train and ...

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in CSV and excellent leadership skills. Roles and Responsibility Lead the development and implementation of CSV strategies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and mitigate risks associated with CSV. Develop and maintain relationships with key stakeholders, including regulators and industry partners. Provide training and guidance on CSV best practices to team members. Conduct audits and assessments to ensure adherence to CSV standards. Develop and implement process...

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy 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, FS, FRA, DD,...

Educational Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities Lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment, contribute to unit level & organizational initiatives Worked as Subject Matter Expert in SD area Experience as a Solution Architect in Logistics, Functional Lead in SD with experience in implementation, Logistics solution (Conducting workshops, Design, Testing, Data Migration and hyper care cutover activities) Strong knowledge of Sales Process, Intercompany transaction, 3PL Logistics, Toll Manufacturing transactions / business processes and best practices Exp...

Educational Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transformation programs Create detailed design and architecture, and process artifacts, implement the solution and the deployment plan Connect with senior client business and IT stakeholders, demonstrating thought leadership in domain, process, and technology Contribute to Unit and Organizational initiatives and COEs Additional Responsibilities: SAP FICO / R2R with experience in any of the following industry (Pharma, ...

Key requirements for this role are as follows: Excellent Communication skills Stakeholder comms Progress updates Comms related to Risk/Issue Outstanding Planning skills (using Agile/SAFe) Scope Clarity and Goal Setting Art of breaking down the work Estimation Work Allocation Risk and Dependency Management Strong Tracking and Monitoring Tracking progress Identifying and Raising Risks Behaviours Accountability/Ownership demonstrated Ability to work cohesively with people/teams Domain Should have preferably worked in Capital Markets Mandatory Competencies Agile - Agile FS Domain - Capital Market Beh - Communication

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: 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, GAM...

: GxP Manual Functional TesterMinimum 4+ years of experience in manual testing in GxP-compliant environments Good understanding of STLC, Functional testing, FIT, UAT, Defect Management Hands on experience in FIT Test case design and executions Hands on experience in UAT test design Working experience with Agile Incremental testing Experience with test management tools (Jira) Understanding of SDLC and Agile methodologies Good communication and documentation skills Collaborate with business, development, and regulatory teams Track and report defects using Jira or similar tools Emailanusha.r@ideslabs.com Location - Chandigarh,Dadra & Nagar Haveli,Daman,Diu,Goa,Haveli,Hyderabad,Jammu,Lakshadweep...

You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. Job description: Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field Minimum 3+ years experience in IT & Software Validation (CSV/CSA, GAMP) Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) Good understanding of system and data risk assessment General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage. Ability to work collaboratively in cross-functional and agile teams to achieve milestones an...

Urgent requirement for Documentum. Experience : 5 Years Location :Pan india Description: Provide technical applications support Work on Defect fixes/new feature development, problem tickets, tasks etc. Work on release and change request activities. maintenance of both production and non- production Documentum environments Promotes standard processes and follow GxP process.

Employment Type: Contract Working Mode : Hybrid 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform