231 Gxp Jobs - Page 9

Sr Associate IS Engineer What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for the testing activities for software applications and solutions that meet business needs and ensuring the availability of critical systems and applications. This role is for a Quality assurance tester and validation analyst for the Clinical Data Management and Interactive Response Technology (CDMIRT) product team. The role involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions. Roles & Responsibilities: Build test scripts per implementation project plan by working with various members of the pr...

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...

Quality Associate Director What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for the development and execution of core technology-based competencies focusing on Artificial Intelligence to enable the Quality strategy aligned with our long-term aspiration and follows the expectations of international regulatory agencies. Support the Quality vision and mission for the Center aligned with Amgen’s mission to serve patients. Support Amgen Site Quality Head in the development and implementation of a multi-year Quality technology roadmap aligned with Amgen’s standards and overall strategic imperatives. Ensure applicable activities align with GxP regul...

Job Title - Lead- SAP Quality Management (SAP QM) Experienced Required- 8-12 Years Role Description: This role shall support global supply chain business team n various areas such a Supply Chain, Logistics, Shipping, inventory Management, Production Supply and related processes The applicant should also have broad knowledge of SAP The applicant should have the ability to support advanced business functions, translate complex business requirements into solution designs, and build and implement systems and technical solutions for operations. Job Requirements: Around 8+ years of experience in the SAP supply chain focused on SAP ERP design, implementation (at least 3 end to end implementation pr...

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...

Skill required.. •Accomplish ITQM objectives in the assigned project by planning, executing and evaluating quality activities (as per service description). Accountable that assigned projects implement security and compliance with applicable laws/regulations like CSV, NVS Standards, the IMF, and project methodology Hands-on experience in Regulatory Compliance (UK DPA, SOX, PII, Data Privacy & Security etc.). Should be able to liaison with the client information security, compliance & legal teams on regulatory requirements & facilitate evidence provisioning during audits • Experience in implementation of at least 2 complete cycles of Information Security Management Systems. Good understanding ...

Develop and implement the company’s IT strategy, aligning with business goals. Oversee the IT infrastructure, including networks, databases, and software systems. Ensure data security and compliance with relevant data protection regulations.

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions in the Regulatory and Clinical Trial submission product team that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers supporting applications like docuBridge Suite from Lorenz and Disclose from Citeline, developing scalable solutions, automating operations, monitoring system health, and responding to incidents to minimize downtime. The ideal candidate will have a strong backgrou...

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...

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. The right candidate should have an exceptional track record of solving pervasive customer problems through strategic thinking, user research and data analysis. You will be involved in every aspect of the product development process, from defining the product strategy and roadmap to driving release milestones with the engineering team. Your Responsibilities include: Help set the product vision and strategy for the ValGenesis product lines Lead problem discovery to understand customer needs, curren...

** 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.

: 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...

#hiring . Know anyone who might be interested? "Ahmedabad Location" Veeda Lifesciences is seeking a passionate "Junior It Administrator". Experience Required: 2-4 years Interested candidates can share an updated CV to mahendra.t3705@veedalifesciences.com 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. Role & responsibilities Infrastructure...

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...

Novo Nordisk Global Business Services (GBS) India Department Commercial DD&IT, GBS Are you passionate about IT validation and compliance? Do you want to play a pivotal role in ensuring regulatory adherence and driving innovation in a global pharmaceutical company? If you have the expertise and enthusiasm to lead in this critical area, we want to hear from you! Read on and apply today. The position As a Lead IT Validation & Compliance at Novo Nordisk, you will be entrusted with the following responsibilities: Ensure IT compliance by monitoring adherence to regulations like GDPR and GxP, aligning systems with evolving standards, and enforcing internal policies. Lead IT system validation by man...

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...

BIOVIA OneLab Foundation Developer with expertise in workflow design, method configuration, and instrument integration. Must have hands-on experience with OneLab 2023 SP2, GxP compliance, and lab informatics in regulated environments.

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 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 sta...

Role & responsibilities Position Summary: We are seeking an experienced Quality Engineer (QE) with a strong understanding of Good Manufacturing Practice (GxP) regulations. The ideal candidate will play a key role in ensuring that our products meet the highest quality standards by supporting manufacturing operations and ensuring compliance with regulatory requirements. The role will require a deep understanding of GxP and the ability to drive continuous improvements in quality systems, processes, and product quality. Key Responsibilities: Lead and support GxP compliance activities, ensuring adherence to FDA, EMA, and other regulatory requirements. Develop, implement, and maintain quality engi...

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 Title: Junior IT Administrator Bioanalytical Lab Support Experience: 2-3 Years Job Summary: The Junior IT Administrator will assist in maintaining the IT infrastructure and systems used in regulated bioanalytical operations within a GLP/GxP-compliant CRO laboratory. This role involves daily user support, troubleshooting, and basic system administration related to lab instruments, LIMS, and networked IT systems. Key Responsibilities: User & System Support Provide first-level IT support for lab users on desktops, applications, and hardware. Troubleshoot issues with instrument PCs, printers, and lab software (e.g., LIMS, Lab Solution, Analyst software). Ensure timely resolution of support t...

Primary Skills: 5+ years of experience in Veeva Vault Clinical (CTMS, eTMF, and/or Study Startup). 5+ years of experience in clinical trial processes and documentation workflows. 5+ years of experience in application support in GxP-regulated environments. 4+ years of experience in Vault Admin Console, security configuration, object lifecycle management. 4+ years of experience in managing support tickets using tools like ServiceNow, Jira, or Remedy. 4+ years of experience with validation (CSV or CSA) and change control procedures. 3+ years of experience managing or mentoring a small team or leading client interactions Role & responsibilities : Lead and manage the application support team for ...

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),...

Your Role Seeking a highly skilled and analytical Biovia d Developer with hands-on experience in BIOVIA ONE Lab , Pipeline Pilot , and ERP-LIMS integration . The ideal candidate will play a key role in designing, developing, and optimizing digital workflows for laboratory operations, ensuring seamless data processing and alignment with business and IT systems. Key Responsibilities: Develop and configure methods and workflows in BIOVIA ONE Lab to support digital lab operations. Design and implement data pipelines using Pipeline Pilot for scientific data processing and integration. Collaborate with IT and lab teams to integrate ERP and LIMS systems with BIOVIA platforms. Analyze business requi...