418 Gxp Jobs - Page 16

Job Title: IT Manager - Infrastructure, Networking & GxP Systems Location: Sarigam Vapi, Gujarat Department: Information Technology Job Summary: We are seeking an experienced IT Manager to lead the IT infrastructure, networking, and production/QC instrumentation functions within our pharmaceutical manufacturing facility . The ideal candidate will be responsible for ensuring compliance with USFDA, GxP, CFR Part 11, and other regulatory IT requirements , while managing IT operations to support manufacturing and quality control. Key Responsibilities: 1. IT Infrastructure & Networking Management Oversee IT infrastructure , including servers, storage, networking, and data centers . Manage enterpr...

Role & responsibilities Job Title: Sr. eCompliance Specialist/Manager Education (minimum/desirable): Degree in Life Sciences, Pharmacy, Engineering, or Information Technology; or similar; advanced degree preferred. Languages: Fluency in English (oral and written), additional language(s) a plus. Experience/Professional requirement: 5-10 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance; CSV compliance. Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle ...

About The Role 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...

Job Description: Quality Assurance Manager Location: Madhapur, Hyderabad Employment Type: Full-Time Job Summary The Quality Assurance Manager will oversee quality assurance processes for our clinical trial software and AI systems, ensuring compliance with global regulatory requirements, including USFDA (21 CFR Part 11), GDPR, HIPAA, ICH-GCP, ISO 90001 & 27001 and other relevant standards. This role requires deep expertise in Computer System Validation (CSV). With 10+ years of experience, the ideal candidate will lead a QA team, collaborate with cross-functional groups, and drive continuous improvement to deliver reliable, compliant, and innovative solutions. Key Responsibilities of a Quality...

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. C...

The Gen AI Team Lead holds a pivotal position within the DigitalX organisation, responsible for multiple value teams under the EnablementX hub. This role involves leading and managing these teams, steering the PODs strategic and tactical goals, and ensuring alignment with the aspirations of the DigitalX leadership. Essential duties include coordinating value teams, developing and implementing roadmaps, coaching team captains, guiding backlog grooming, leading POD management standups and retrospectives, consolidating value team statuses at the POD level, and working closely with the hub leadership team. Responsibilities: Lead and guide teams and team captains, assisting in the planning and ex...

Job title TOSCA automation Tester Job mode : Remote Location : Any were in India Work mode : Long term Contract More than 1 year Note : This is totally Remote in India need to travel once in a Month Near by location to client place Job Description: Strong have analytical and problem-solving skills as well as the ability to decompose complex problems and perform root cause analyses in troubleshooting customer issues in tosca. 8-10 Years of hands-on experience in Tosca Should have knowledge on DEX integration Should have knowledge on day-to-day activity like repo creation, User access management and other operations activity Should have knowledge on Windows server for performing activities lik...

Role & responsibilities PAYROLL ORGANIZATION : VALUE INNOVATION LABS https://valueinnovationlabs.com/ Preferred candidate profile Title: Technical Product Owner Work Location - Bangalore Qualifications: • Bachelors degree in Computer Science, Information Technology, Business Administration, or a related field, or equivalent by experience. Masters degree or relevant certifications are a plus. • 5+ years of experience in product management or product ownership, with at least 3 years focused on Governance Risk and Compliance, enterprise risk management technologies or similar solutions. • Experience shaping integrated risk management dashboard, providing centralized views of risk activities and...

Work profile: Plant IT Operations (Pharma and Biotech) Job Location: Bangalore Qualification: Diploma or Degree in Engineering Experience: 7-10 years (L2) Duration : 1 year contract Role & responsibilities: Installation of OS and application-level critical updates, Service packs, and security patches on workstations. Performance monitoring of all Servers, Desktops, and Networking devices. Installation and troubleshooting of operating systems and software, ensuring efficient deployment and resolution of issues. Applying the OS patches and upgraded administrative tools, maintaining the latest system updates and utilities for optimal performance and security. Remote support to end-users for ent...

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-fun...

MDM Business Performance Manager What you will do Let’s do this. Let’s change the world. In this vital role you will lead the optimization of master data processes across Amgen’s global operations, ensuring data quality, consistency, and governance. They are responsible for driving continuous improvement initiatives, and strategic projects, focusing on improving data accuracy, reducing process inefficiencies, and aligning data management practices with business objectives. This role will collaborate with IT, Supply Chain, and other key stakeholders to ensure that MDM processes support operational needs and regulatory compliance. Roles & Responsibilities: Lead the development and implementati...

Mgr Information Systems What you will do Let’s do this. Let’s change the world. In this vital role you will responsible for leading 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 lead tester and validation expert with functional and system knowledge for Clinical Data Management, Interactive Response Technology (IRT) solutions. The role involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions. Roles & Responsibilities: Participate in requirement discussions related to the RBM / RBQM system(s) wit...

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...