231 Gxp Jobs - Page 5

Greetings from HCL! Currently Hiring for "Validation" JD: Computer System Validation (CSV) Good Documentation Practices (GDP) Regulatory Compliance (GxP, FDA 21 CFR Part 11, EU Annex 11) Risk Assessment & Management & SDLC Experience - 5-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda...

Minimum 10 - 12 years of experience in handling complex large transformation projects Experience in Client Relationship Management – key client stakeholders, understanding their requirements and Outsourcing ability to meet them Experience of leading large teams located across multiple cities in India and across the world. Experience of Driving Digital Transformation across a portfolio of accounts Demonstrates a breadth and depth of operational service delivery management expertise. Preferred: Ability to create technical designs based on functional designs, including, mockups, process and data flow diagrams, etc Ability to gather critical information from meetings with various stakeholders an...

As a Senior Principal at Infosys Consulting dedicated to serving Life Sciences firms globally, you will play a crucial role in managing transformations from strategy setting to execution, ensuring the delivery of realized business value. We are looking for individuals with exceptional communication skills, intellectual curiosity, and a strong passion for ethics and compliance management, particularly in the field of Risk & Compliance within Life Sciences. Your responsibilities will include conducting comprehensive risk assessments of AI applications, ensuring compliance with relevant regulations and standards, developing risk assurance frameworks specific to AI technologies in life sciences,...

We have an exciting opportunity for a Manager IT-MES & L2 project coordinator at our Halol/Baska(Gujarat) location. As a seasoned professional with 7-9 years of experience in the pharmaceutical industry, you will be responsible for overseeing Manufacturing Execution Systems (MES) and L2 integration. Your role as the Site Project coordinator for MES Implementation will involve coordinating all MES-related activities at the Halol / Baska sites. It is essential that you provide dedicated full-time support to the project to ensure smooth execution, alignment with the global MES strategy, and timely delivery of milestones to enhance manufacturing efficiency, compliance, and digital transformation...

Experience in CSV, GAMP, GXP, 21CFR, Part11. Experience in Documentation Writing Good Communication skills. NP - Immediate to 15 Days

Job Type: Full-Time Experience Level: 5+ years in MES / Automation domain with strong expertise in Siemens Opcenter EXPH Job Summary: We are seeking a skilled and experienced Siemens Opcenter Execution Pharma (EXPH) Consultant to join our dynamic team. The ideal candidate will have hands-on experience in installation qualification, development, configuration, and upgrades of Opcenter EXPH, as well as a strong background in MES, SCADA(Optional), Automation, and related software systems. Key Responsibilities: Lead and support installation qualification, upgrades, patching, and configuration of Siemens Opcenter EXPH . Perform development and customization tasks including electronic recipe desig...

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...

Zoetis, Inc. is the world's largest producer of medicine and vaccinations for pets and livestock. Join the Zoetis Tech & Digital (ZTD) Global ERP organization at Zoetis India Capability Center (ZICC) in Hyderabad, where innovation meets excellence. As part of a leading animal healthcare company, ZICC is dedicated to driving transformative advancements and applying technology to solve complex problems. The mission is to ensure sustainable growth and maintain a competitive edge for Zoetis globally by leveraging exceptional talent in India. As a member of ZICC, you will collaborate with colleagues worldwide, embodying the spirit of One Zoetis. Together, seamless integration and collaboration ar...

Efficiently monitor all operations which affect the quality. Devise procedures for inspecting and reporting all the persisting quality issues. Assure the consistency and reliability of production with thorough checking procedures and final output. Supervise and guide inspectors, technicians, and all other staff. Report all malfunctions to production executives only to ensure immediate action. Appraise all the requirements of customers and ensuring they are quite satisfied. Facilitate proactive solutions by collecting and analyzing quality data. Keep permanent records of quality reports, statistical reviews, and relevant documentation. Review the current standards and policies. Communicate wi...

Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the o...

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, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system f...

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,...

Role Description: GxP Expertise: Conduct GxP compliance assessments for SAP systems and processes. Develop and implement GxP validation plans for SAP modules within supply chain, quality management, and manufacturing. Ensure documentation and procedures meet GxP requirements Prepare all the GxP Documentation and Protocols Execute all the GxP Protocols Validation and Compliance: Participate in the validation of SAP systems and processes for GxP compliance. Prepare and manage validation documentation (plans, reports, etc.). Liaise with regulatory agencies during inspections and audits. Stay updated on evolving GxP regulations and industry best practices. Preferred candidate profile Bachelor's ...

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