418 Gxp Jobs - Page 15

Greetings for day. We are having opening for the role Manager - QMS & Documentation Management in Corporate Quality Department. Department : Corporate Quality Location : Mumbai - Andheri East Qualification - B. Pharm. / M. Pharm / M. Sc. Industry Preferred : Pharmaceutical. Work Experience :12 - 18 years Corporate Experience only. Job Description : Quality Management System (QMS) Oversight: Ensure robust implementation and periodic / Retrospective review of all QMS elements including Change Control, Deviation, CAPA, Risk Management, and Quality Review. Documentation Lifecycle Management: Coordinate periodic SOP revision cycles. Ensure alignment with current practices, regulations, and audit ...

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...

Experience:- 2+ Years. Location:- Electronic City, Bengaluru. Skills:- Authorising, Reviewing, Validation Documents Minimum Qualifications expected for the candidates • Degree in computer engineering / equivalent. with CSV especially in IT pharma enterprise systems • Strong communication skills • A comprehensive understanding of GxP, GAMP 5, Infrastructure Management, Computerized System Validation, (Initial Risk Assessment, Disaster Recovery Process, Data Security etc), and QMS. • Proficiency in project and stakeholder management

Role: System Administrator Department: IT Location: Bidar About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opport...

Information Security GxP Specialist What you will do Let’s do this. Let’s change the world. In this lead role you will support the GRC Governance / Policy & Audit team working closely with Technology teams to help ensure that GxP controls are in place, GxP deviations are managed and monitored, and security standards are met. The GxP Specialist will assist in owning and maintaining GxP deviation records, performing GxP assessments, managing controlled documents, and supporting regulatory compliance efforts. Roles & Responsibilities: GxP Governance Leadership: Support the GRC organization in leading a team of GxP and/or policy analysts performing tasks related to governance, GxP deviation mana...

About The Role Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgen’s Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, help...

Let’s do this. Let’s change the world. In this vital role you will serve as a Technology supervising the delivery of enhancements and integrations for Medical Information Websites. You will handle full lifecycle project execution — from planning through delivery — while ensuring alignment with global product strategy, GxP/CSV requirements, cybersecurity standards, and Amgen’s governance model. This role also requires close coordination across functional and technical teams, including business collaborators, Salesforce development teams, product analysts, QA/validation, and global platform teams. You will also serve as a liaison between onsite and offshore teams, ensuring seamless collaborati...

Job Information Job Opening ID ZR_1871_JOB Date Opened 14/04/2023 Industry Technology Job Type Work Experience 8-12 years Job Title Architect City Bangalore Province Karnataka Country India Postal Code 560048 Number of Positions 1 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. H...

Dear Candidate Hope you are doing well My name is Bhavani, I am a recruiter from Yallas Technology solutions We are Hiring a job opportunities. please find the position details below. Title: Computer System Validation (CSV) Expert( SAP CSV) Duration: Permanent Position Location: Hybrid/work from home(if client asked, need to work at client location) Notice period- Immediate - 7 days Job Description: You have successfully completed studies in the field of computer science, engineering or a related field. • You are passionate about ensuring compliance and quality in software solutions tailored for the life sciences industry. • You have minimum of 5 years proven experience in the field of CSV /...

Job Role: CQV Engineer Experience: 2-4 years Location: Bengaluru Key Responsibilities: Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc. Participate and coordination with engineering & OEMS for FAT/SAT. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM. Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment. Perform Qualification as per the regulatory requirements (e.g., FDA, WHO) Should have sound knowledge in good documentation Pr...

BDM: CSV/GxP Consultancy Sales *Hunt new clients (Pharma/Biotech/Med Device). Deep CSV/GxP knowledge (3+ yrs sales req). Build relationships, close deals. Travel 50-60%. Competitive base + uncapped commission. Impact patient safety.*

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collabo...

Role Description? The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with business stakeholders, Data engineers, AI/ML engineers to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Owner and developers to maintain an e...

Role Description? The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with business stakeholders, Data engineers, AI/ML engineers to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Owner and developers to maintain an e...

Role Description? This role involves working closely with Business Analyst Data architects, Data engineers, AI/ML engineers and Product Managers to ensure that Validation strategy and deliverables are produced for IT Systems. 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 validatio...

At Smith+Nephew , we design and manufacture technology that takes the limits off living! The IT Business Analyst for Regulatory Affairs will collaborate with business leaders and product owners to define, justify, and deliver IT solutions that meet business objectives, create competitive advantage, and leverage internal and external IT resources. Responsibilities include contributing to strategy, gathering requirements, advising on industry trends, building capability roadmaps for short- and long-term needs, and analyzing processes for improvement and cost-benefit. What will you be doing? Provides Business Analysis and Requirements management in support of Regulatory Affairs group Elicit, de...

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...

We are looking for Automation Test Engineer - GXP Validation professionals for our IT services division. who is having experience in below technical stack. Please revert if you are interested with below requested information. Required Skills: Selenium with Java, Automation, Rest Assured, API testing, Bdd frameworks, GXP, / Good x Practice. Qualification: UG / PG Graduates Experience: 5-10 Years Location: Chennai / Coimbatore / Bengalore / Pune Work Time: 2pm to 11pm Work Mode: Hybrid Model (3 Days work from office) Notice Preferred: 0-30 Days. Preferred Project experience: Healthcare, Life science. Responsibilities: Develop and maintain automated test scripts and frameworks. Perform function...

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and doc...

We are looking for a strategic and seasoned Manager / Sr. GM - Human Resources to lead and elevate our Human Resources function at Chieron Active Ingredients Pvt Ltd. This critical leadership role will oversee the entire HR department across multiple locations, ensuring the effective implementation of HR policies, fostering a positive and productive company culture, and driving strategic HR initiatives aligned with business objectives. The ideal candidate will possess deep expertise in stakeholder management, industrial relations, contract workforce management, compliance, audit & governance, talent acquisition & development, HR operations & policy governance, and strategic HR leadership. Th...

Summary Are you a seasoned Automation Engineer with a passion for cutting-edge technology and a desire to revolutionize manufacturing processesIf so, we invite you to join us as an Associate Director ITOT Automation Engineer at Novartis, As an integral member of our team, you will play a critical role in defining and implementing the automation concept for both our new and existing manufacturing facilities Your expertise will be instrumental in ensuring that our automation designs and equipment are aligned with IT/OT standards, while leveraging the latest technologies available, In this pivotal position, you will be involved in a wide range of investments, collaborating with cross-functional...

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...

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningf...

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningf...

We are seeking an experienced professional for the role of Assistant Manager, Computer System Validation (CSV) to join our Risk Advisory team. The ideal candidate will have a strong background in computer system validation within the life sciences and pharmaceutical industry, with a deep understanding of regulatory requirements and validation methodologies. Job Description- Computer System Validation (Assistant Manager) At least 6-7 years of computer system validation experience in a Life sciences and pharmaceutical environment. Good knowledge of cGxP regulations and software lifecycle approaches (e.g., 21 CFR part 11, EU Annex 11, GAMP 5, SDLC Waterfall/Agile methodologies) Having knowledge...