15 of 15 Remote 21 CFR Part 11 Jobs

centers. It's a hybrid position that will allow you to combine work at home and on customer site. You are also an integral part of an Akkodis platform, within our customer teams, which means you'll have daily follow-up and support from people who know your work … for improvement in existing processes to enhance the efficiency and performance of data analysis. o Ensure IT systems comply with regulatory requirements (GxP, FDA 21 CFR Part 11, Eudralex Annex 11, etc.). o Participate in risk assessments and define validation strategies tailored to each … o You have knowledges of data management tools (advanced Excel, Power BI, SQL or equivalent). o You are familiar with GxP standards, FDA 21 CFR Part 11, and/or EU Annex 11 guidelines. o You have experience or high affinity with computer/ More ❯

years of experience in a pharmaceutical or regulated QC environment with a focus on delivering solution. You have excellent understanding of GxP regulations, 21 CFR Part 11, Eudralex Annex 11 or other international requirements. You are proficiency in French and English, both written and spoken. More ❯

field. Experience in pharmaceutical, biotech, or healthcare technology sectors. Prior involvement in achieving compliance in both SOC 2 and GxP contexts. Familiarity with FDA 21 CFR Part 11, EU Annex 11, or similar regulations. What We Offer A key role in a high-impact compliance More ❯

quality and compliance. The company's solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001. Who we're looking for Dot … Competitive salary and benefits package. Generous PTO/Vacation plan. Paid holidays. 401(k) plan with company match. Remote work environment. Opportunity to be part of a dynamic and growing team. Responsibilities: Maintain consistent digital interactions with customers, providing support and assistance as needed. Manage and negotiate renewal & expansion More ❯

Scientific Business Analyst Research Informatics Amgen South San Francisco Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the … culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Scientific Business Analyst Research Informatics What you will … in a research laboratory or vivarium. Regulatory knowledge: Experience handling GxP data and system validation. Knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP). Scientific Software Expertise : Experience using or supporting platforms from scientific software providers such as Genedata More ❯

s your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey to make healthcare more efficient through Technology. Salary: Up to £65,000 + Bens Location: Fully Remote (UK) The Role We … API-based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and More ❯

s your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey to make healthcare more efficient through Technology. Salary: Up to £65,000 + Bens Location: Fully Remote (UK) The Role We … API-based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and More ❯

s your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey to make healthcare more efficient through Technology. Salary: Up to £65,000 + Bens Location: Fully Remote (Portugal/UK) The … API-based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and More ❯

s your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey to make healthcare more efficient through Technology. Salary: Up to £65,000 + Bens Location: Fully Remote (Portugal/UK) The … API-based data exchange , data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and More ❯

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds … culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manufacturing Systems Engineer: Automation What you will … and DeviceNet technologies. Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95. Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development More ❯

and implement small projects in accordance with software/system development life cycle principles; Contribute to computer systems validation activities as they relate to 21 CFR Part 11 & GxP compliance (e.g. user requirements gathering & definition, authoring of technical specification documents, authoring user acceptance tests); Analyze user More ❯

contribute to the CSV functional strategies and long-term roadmap. Maintain knowledge of industry standards; FDA Computer System Validation Guidelines, FDA Computer System Assurance, 21 CFR Parts 210, 211, 11, 820, EU Annex 11, ISPE GAMP5, as it relates to computer systems used at BioMarin. Participate … Experience in Deviations, CAPAs and Change Control Management • Strong background and implementation experience on industry regulations (e.g., FDA CSV, FDA CSA, 21CFR210, 211, 820, Part 11, Annex 11, ICH Q9, Q10) and guidance's (e.g., ISPE GAMP, MHRA) • Good knowledge and implementation experience on Data Integrity requirements More ❯

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds … culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Principal Manufacturing Systems Engineer (Delta-V, Rockwell) What … drawings, and Standard Operational Procedures (SOP) including Administrative SOPs and Job Plans. Conversant with industry standards on quality and regulatory compliance requirements such as 21 CFR Part 11 (Data Integrity, User Security, System Disaster Recovery, Data Backup & Restore). Support a Safe working environment by aligning More ❯

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds … culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manufacturing Systems Engineer What you will do … Lets do this. Lets change the world. In this vital role you will be part of Amgen's newest and most sophisticated final product assembly and packaging plant. The Final Product facility will not only feature the best in-class device assembly and packaging technologies with embedded industry 4.0 More ❯

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds … culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manufacturing Systems Engineer What you will do … Lets do this. Lets change the world. In this vital role you will be part of Amgen's newest and most sophisticated final product assembly and packaging plant. The Final Product facility will not only feature the best in-class device assembly and packaging technologies with embedded industry 4.0 More ❯