16 Gamp 5 Jobs

Planning and performing of Computer Systems Validation in regulated environment. Respond CSV schedule to ensure all quality, manufacturing and engineering systems remain qualified to current GxP and GAMP5 requirements. IT systems interface Required Candidate profile Working knowledge on US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5. Develop CFR Part 11 csv plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols; IT system interface

Job Description: What are we looking for Analysts Consultants Senior Consultants We are looking for smart self driven high energy people with top notch communication skills intellectual curiosity and passion for excellence Our analysts have a blend of in depth domain expertise strong analytical and conceptual thinking skills and excellent soft skills We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation Risk Management and Audits2 14 years of professional experience in Life Sciences industry working for a consulting services organization and or industry experience Understanding of key pharmaceutical compliance regulati...

Job Description GxP Validation & Compliance Specialist (Contract) Position Type: Contract (6 Months) Open Positions: 01 Location: Bangalore (Preferred) Experience Required: 46 years Role Overview We are looking for a skilled GxP Validation & Compliance Specialist to ensure that all digital twin workflows comply with global regulatory requirements, including 21 CFR Part 11 and EU Annex 11 . The specialist will lead Computer System Validation (CSV)/Computer Software Assurance (CSA) activities, manage compliance documentation, and provide expertise in pharma quality systems. This role will play a key part in enabling compliant deployment of advanced digital solutions. Key Responsibilities Lead ...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Cytiva, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological re...

Immediate joiner who can join within a week time with having experience in CSV, QC area. Hands on Quality Control system- software as, Chromeleon, TIAMO, LAB Solution. Knowledge of 21 CFR Part 11, GAMP 5 GDP, GMP. Preparing documents GxPA, URS, VPP,

We are seeking a skilled IT CSV (Computer System Validation) Executive to join our pharmaceutical team in Vadodara. The ideal candidate will ensure compliance with regulatory standards, optimize IT systems, and support validation processes critical to our operations. Key Responsibilities: Perform validation activities for IT systems, including documentation, testing, and implementation, in compliance with GxP and regulatory guidelines. Develop and execute validation plans, test cases, and protocols for IT systems. Conduct risk assessments and mitigate risks associated with IT systems and software applications. Ensure compliance with industry regulations such as 21 CFR Part 11, GAMP 5, and ot...

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watchv=tASq7Ld0JsQ About the Role: Improve compliance through continual improvement programs across the organization and Quality by design. Responsibilities Overall change and review responsibility for Quality Management Processes in l...

1. Strategic Leadership Develop and implement maintenance strategies aligned with business goals and global standards Lead cross-functional shutdown planning and execution, including coordination of asset investment programs Represent the maintenance function in steering committees and regulatory inspections 2. Operational Oversight Oversee daily maintenance activities for production equipment, utilities, HVAC, cleanrooms, and support systems Ensure preventive and predictive maintenance programs are executed effectively to minimize downtime and extend equipment life Manage CMMS systems, work orders, spare parts inventory, and vendor contracts 3. Team Management Supervise and develop maintena...

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their busines...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Cytiva, one of 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research ...

Key Responsibilities: Audit Readiness (IT Focus) Ensure IT systems, documentation, and infrastructure are always audit-ready for external and internal audits. Lead or support IT-related audit sessions, walk-throughs, and responses during sponsor audits , regulatory inspections , and internal QA reviews . Maintain an organized repository of IT evidence including SOPs, validation documentation, access logs , and change control records . IT Compliance & Documentation Author, review, and maintain IT SOPs , Policies etc. in accordance with regulatory requirements. Ensure that IT documentation complies with 21 CFR Part 11 , EU Annex 11 , and GAMP 5 guidelines. Conduct periodic reviews of IT system...

JOB OVERVIEW: To perform and author Computer System Validation activities of GxP Computerized as per defined processes at Corporate IT and across Piramal Pharma sites. KEY STAKEHOLDERS: INTERNAL Business Site / Corporate functions IT Team (e.g. SAP/ Infra / Quality IT / Allied / SAP Basis) KEY STAKEHOLDERS: EXTERNAL IT Vendors IT Contractors/Consultants REPORTING STRUCTURE: Will report to Chief Manager- IT CSV EXPERIENCE: Candidate with 3- 6 years of experience in Pharma/Life science domain working knowledge in authoring on Computer System Validation Deliverables, Part 11/Annex 11, Data Integrity Work experience in Pharmaceutical Sector will be desirable SKILLS AND COMPETENCIES Experience in...

Key Responsibilities: What are we looking for Analysts Consultants Senior Consultants We are looking for smart self driven high energy people with top notch communication skills intellectual curiosity and passion for excellence Our analysts have a blend of in depth domain expertise strong analytical and conceptual thinking skills and excellent soft skills We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation Risk Management and Audits2 14 years of professional experience in Life Sciences industry working for a consulting services organization and or industry experience Understanding of key pharmaceutical compliance reg...

Job Description: A day in the life of an Infoscion As part of the Infosys consulting team your primary role would be to actively aid the consulting team in different phases of the project including problem definition effort estimation diagnosis solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys information available in public domains vendor evaluation information etc and build POCs You will create requirement specifications from the business needs define the to be processes and detailed functional designs based on requirements You will support configuring solution requirements on the ...

Job Description: Proffered Profile: Bachelors degree (BE/B tech) with 3-5 years of experience in IT QMS Compliance Specialist ensures alignment of all IT systems, processes, and documentation with internal Quality Management Systems (QMS) and applicable regulatory standards such as GxP, ISO 9001, 21 CFR Part 11, and EU Annex 11. This role plays a key part in audit preparedness, deviation management, and maintaining consistent quality across IT operations and projects. Key Responsibilities: Develop, implement, and maintain IT quality policies, SOPs, and work instructions in accordance with QMS. Ensure compliance of IT systems with relevant regulatory requirements (GxP, 21 CFR Part 11, GDPR, e...

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 validation and meets our regulatory and v...