418 Gxp Jobs - Page 12

Novo Nordisk Global Business Services (GBS) India Department Centralised Monitoring Unit, CDS GBS - Bangalore Are you passionate about what you are doingDo you want to build excellence within processes in the most efficient wayDo you have innovative mindset to drive change in a future-ready environmentAre you best at what you doIf so, raise your hand as there is an exciting opportunity waiting for you as an "Senior Functional Programmer " with us. "" At Novo Nordisk, we assure you will experience the best. About the department Bangalore Global Development since its inception, has transitioned from a small start-up to one of the largest units in Global Business Services, Bangalore (GBS) and a...

Novo Nordisk Global Business Services (GBS) India Department Centralised Monitoring Unit, CDS GBS - Bangalore Are you passionate about what you are doingDo you want to build excellence within processes in the most efficient wayDo you have innovative mindset to drive change in a future-ready environmentAre you best at what you doIf so, raise your hand as there is an exciting opportunity waiting for you as an "Functional Programmer " with us. "" At Novo Nordisk, we assure you will experience the best. About the department Bangalore Global Development since its inception, has transitioned from a small start-up to one of the largest units in Global Business Services, Bangalore (GBS) and a key co...

Job Title: CSV Engineer Location: Bangalore Experience: 2-4 years Industry: Pharmaceutical / Biotechnology / Lifesciences About the Role: We are looking for a CSV (Computer System Validation) Engineer with hands-on experience in the pharmaceutical, biotechnology, or life sciences sectors. You will be responsible for ensuring that systems are validated in compliance with regulatory requirements and internal quality standards. Key Responsibilities: Perform validation activities for GxP computerized systems (planning, risk assessment, URS, IQ, OQ, PQ, summary reports) Prepare and review validation documentation in line with 21 CFR Part 11, EU Annex 11, and other regulatory guidelines Conduct im...

Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule. Primarily performing internal audits of CTO, FTO and R&D Sites. Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites. Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessmen...

Position Summary: We are seeking a highly experienced and driven Business Analyst to lead and manage Product digital and IT initiatives within the pharmaceutical/life sciences sector. The ideal candidate will have strong experience in Business analysis, stakeholder engagement, and driving execution across multiple workstreams, while ensuring compliance with regulatory and quality standards. ______________ Key Responsibilities: Lead end-to-end product management for IT/technology initiatives in the pharma/life sciences domain, ensuring requirement gathering , gap analysis , process flows modelling documentation practices and technical document writing. Experienced in data analysis (SQL, ETL e...

OVERALL OBJECTIVES: As a senior member of the team, you will join a challenging and unique large-scale Transformation Program with high impact and visibility. Primary focus is the assessment, planning and implementation of new or improved IT Services as part of the project engineering team. Senior Reliability Engineer (SRE) is primarily responsible for the engineering, configuration, installation, and maintenance of; Windows physical and virtual servers, Active Directory, Azure cloud and on-prem environments based on Hyper-V/VMWare, storage, backups, and disaster recovery planning. We rely on our engineers to empower our users with high availability, excellent performance levels and key serv...

We are looking for a Computer System Validation (CSV) Engineer with specialization in SAP HANA/S/4HANA validation to join a prestigious MNC Pharma company at their corporate headquarters in Mumbai. As a CSV Engineer, your main responsibilities will include developing and overseeing CSV deliverables such as VP, URS, FRA, IQ/OQ/PQ, etc. It is essential to ensure adherence to regulatory standards like 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborating with diverse teams including QA, IT, and BPOs will be a key aspect of your role. Additionally, managing SAP system upgrades, patches, and audits will be part of your day-to-day tasks. The ideal candidate should hold a Bachelor's degree in Comp...

Trackwise Consultant Experience: 5 to 8 Years Location:- Bangalore/Pune/hyderabad Notice period : Immediate to 15days Job Description Knowledge of Trackwise is a must Should have indepth knowledge of handling Quality management in TrackWise Should have a strong understanding of Trackwise Business processes such as Change Management System IncidentDeviation Investigation CAPA implementation etc Should have a deep understanding of the individual workflowsapprovals in each Trackwise Module Experienced in generating various types of queries in TrackWise requirements Well versed knowledge of Quality Risk assessment through TrackWise Application Should have managed QMS implementation projects incl...

1.Responsible for Sample Management Activities like Sample collection, Handling, Labeling, Tracking, Chain of custody documentation and Sample Disposal 2.Responsible for arranging the samples to be sent to the vendor for the required external testing and receiving the appropriate reports 3.Responsible for following GLP/GDP practices and Compliance with respect to sample management. 4.Responsible for reagents / chemicals / standards / consumable / utilities receiving, labelling, proper maintenance, consumption records listing of procurements requirements.

We are looking for a skilled Kneat CSV Professional with 6-12 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in Recruitment / Staffing and excellent skills in Kneat CSV. Roles and Responsibility Manage and implement Kneat CSV solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain technical documentation for Kneat CSV projects. Provide training and support to clients on Kneat CSV tools and features. Troubleshoot and resolve issues related to Kneat CSV implementation. Analyze and optimize client data processing workflows using Kneat CSV. Job Require...

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clien...

CSV L1/L2 Support Validating, Reviewing and updating validation documentation Hands on exp in CSV principles and GxP compliance. Experience in validation practices with hands on exp in 21 CFR Part 11/ EU Annex 11 /GAMP 5 Guidelines /GxP Standards

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 ...