142 Gamp Jobs - Page 6

Validation Engineer I What you will do Let’s do this. Let’s change the world. We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to va...

Work with us We are looking for a determined and dedicated Advanced Engineer for ProcessAutomation who can provide innovative solutions in complete life science andpharmaceutical projects. This also includes understanding the clients complexprocess facilities, with Good Automated Manufacturing Practice (GAMP) regulatedrequirements for a pharmaceutical production facility. Our department consistsof dedicated engineers, specialized in different phases of the project includingConceptual Design, Basic Design, Detailed Design, Commissioning andQualification. How you might spend your days As an AdvancedEngineer for Process Automation, you'll be working with a motivated, multi-functionalteam where ...

Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role Are you passionate about delivering exceptional service and revolutionizing the world of technology? We have an incredible opportunity for a talented individual to join our dynamic team as a Plant IT Operations Lead. In this customer-centric role, you will play a pivotal role in ensuring our customers receive top-notch service within a contract...

Candidate must have hands on experience in Werum PAS-X/FTPS development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES components such as EBMR...

** VEDIO CALL INTERVIEW ** Roles and Responsibilities Perform CSV (Computer System Validation) tasks for new systems implementation. Ensure compliance with GMP regulations during software validation processes. Conduct software validation activities according to GAMP guidelines. Key Skills : Good Exposure on CSV,PLC, Software Validation in pharmaceutical industry, SAP,LIMS Qualification, TRIMS,NICHELONS,HVACMS/BIMS,EMPOWER,ELMS. ** Preferred male candidate only. Interested candidate can share their resumes below mail id: sonali.n@hetero.com/9100408534. Job Location : Unit V, Hetero Labs limited, Jadcherla, Hyderabad.

Role Responsibilities Support and improve the performance and maintainability of automation systems already in the field. Troubleshoot complex issues involving PLC, SCADA, and HMI systems, and drive root cause investigations. Collaborate with service and support teams to resolve customer-reported issues and develop effective solutions. Provide coaching and technical documentation to support junior engineers and cross-functional teams. Contribute to product documentation and ensure compliance with GMP, GAMP, FDA, and other regulatory standards. Participate in automation system improvements, contributing ideas to enhance standardization, modularity, and usability. Minimum Qualifications Bachel...

Responsibilities and Duties Preparation and review of Validation deliverables such as URS, GxP, Impact Assessment Checklist, VP, Specification documents (SDS, FRS, TS, CS), FRA, IQ Protocol & Scripts, OQ Protocol & Scripts, PQ Protocol & Scripts, DM (Data Migration) Protocol & Scripts, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist as per Webosphere CSV SOP. Execution/Support in the execution of IQ, OQ, PQ, and DM test scripts on the internal as well client side. Basic knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, EU Annex 11, GAMP5. Coordinate with Client to carry out Validation activity of Computer...

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 Summary: We are seeking a highly skilled and detail-oriented Computer System Validation (CSV) Consultant with proven experience in validating SAP systems (SAP ECC, SAP S/4HANA, SAP GxP modules, etc.) within regulated environments such as the pharmaceutical, biotechnology, or life sciences industries . The ideal candidate will be responsible for ensuring SAP systems are compliant with GxP regulations, 21 CFR Part 11, Annex 11 , and other applicable standards by leading and executing validation activities throughout the system lifecycle. Key Responsibilities: Lead and perform CSV activities for SAP systems, including validation planning, risk assessments, and test script development (IQ/OQ...

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...

Job Title: Senior IT Administrator Bioanalytical Support Experience: 3-5 Years Job Summary: The Senior IT Administrator will be responsible for managing and supporting the IT infrastructure, systems, and applications critical to bioanalytical operations within a GLP/GxP-compliant CRO. The role ensures high availability, compliance, and performance of IT services supporting regulated lab environments, including LIMS, chromatography software, and instrument data acquisition systems. Infrastructure & System Support Manage and maintain lab-related IT infrastructure including servers, workstations, storage, and backup systems. Administer Windows Server environments, Active Directory, Group Polici...

Job Location: Ahmedabad Experience Year : 3-5 Years Qualification: Bachelors Position: QA-CSV Job Type: WFO Company Name: GSC Technolabs. A Group of GSC Technologies Ltd. Key Job Responsibilities for a QA-CSV Role: Validation Planning: Develop and maintain Validation Master Plans (VMP). Define a validation strategy based on risk and regulatory impact Documentation: Create and review validation documentation, including: User Requirements Specifications (URS) Functional Specifications (FS) Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) Traceability Matrix Final Validation Reports Testing & Execution: Lead or perform Installation Qualification (IQ), Operational Qualification (OQ),...

Sikich is seeking an experienced Validation Analyst to join our dynamic team and contribute to our commitment to quality and compliance in the field of computer systems validation. Primary Job Responsibilities: Develop/design OQ, PQ scripts along with RTM mapping Perform dry run, formal execution and Issue re-testing Maintain constant communication with management and peers Create FRS, Validation plans, if required Create any training repository and leveraging existing team's knowledge Provide value adds to the project/organizations Requirements: Must Have Experience: Computerized system validation (CSV), including knowledge on FDA 21, CFR Part11 and GAMP Experience in electronic / paper-bas...

Role & responsibilities Monitoring Backup jobs training the documentation, and keeping to IT Head approval. Responsible for tracking hardware and software inventory in the ticketing tool. Updating the IT assets Maintaining the labels for all IT assets. Responsible for the Backup Responsible for GMP-related queries and prepared the documentation IT-related bills are filed and kept for approval. PCB-related onsite support and coordinating with vendors supported by the reporting Head. Monitoring and maintaining the CC Cameras infrastructure and escalating to the head if anything is critical. Troubleshooting third-party applications at the Unit level and escalating to the reporting Head to get s...

Hiring manager and Recruiter should collaborate to create the relevant verbiage. Your Role and Responsibilities Work with Development, Product Management, Security, Support, Legal, Customer Success, and other partners to complete Release Management tasks for software products Coordinate with development and stakeholders to set and manage scope, and to prioritize and schedule release activities Develop release plans, timelines, and milestones, and drive the team to finish tasks on time with high quality Facilitate communication to ensure smooth collaboration across different teams Help fix problemsUnderstand the context, get people talking, get to the bottom of it, get action plans and target...

Experience: 2+ years I Industry/ Domain: Fund Administration Apex Group Ltd has an immediate requirement for a FIS Investran Techno-Functional Senior Associate for its Fund Services business within the Private Equity & Real Estate Funds (PERE) division. The principal responsibilities for the job are managing client reporting request, monitoring the Investran database, enhancing the technical product and supporting operational excellence. . The role requires. Design, develop and implement high quality reports for our global Private Equity clients and their investors. Knowledge of PE GL Suite FIS Investran is a must. Promote product knowledge and team initiatives key PE forums such as the Inve...

India's marquee global technology company. They are an international flag-bearer of technical and managerial excellence. With offices around the globe, the company has a comprehensive presence across multiple segments of the IT product and service industries. They are a respected career company and a long-term wealth creator. Location: Hyderabad/Bangalore/Chennai/Pune/Mumbai/Delhi/NCR/Kolkata Purpose of the role & key responsibilities: Lead project compliance work streams, responsible for end to end quality and compliance aspect of the project, validation deliverables, client buy-in and reporting leading to successful project delivery and client delight Engage with key stakeholders for execu...