- Takeda Pharmaceuticals (Boston, MA)
- …of best practices and cutting-edge methodologies. + Drive the development and validation of computational models, leveraging deep expertise in in silico approaches. ... technologies and processes + Extensive familiarity with regulatory compliance standards ( FDA , EMA) relevant to pharmaceutical operations + Proficiency in Project… more
- Sanofi Group (Framingham, MA)
- …teams, including Quality, Manufacturing Technical Support, Facilities and Engineering, and Validation . + Strong understanding of Good Engineering Practice, GMP and ... Knowledge: Familiarity with pharmaceutical industry regulations, including FMP and FDA standards. + Experienced with Deviation Management Systems (ie Trackwise).… more
- BrightSpring Health Services (Hudson, MA)
- …Pharmacist. + Complete all calculations on product preparation and obtain validation from the Pharmacist before compounding/mixing. + Compound sterile admixtures and ... meetings and quality improvement activities. + Adhere to all accreditation, OSHA, FDA , state, local and federal regulations and standards relevant to infusion… more
- Sanofi Group (Cambridge, MA)
- …development activities (eg pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment) + Contribute to the clinical ... part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health… more
- Sanofi Group (Cambridge, MA)
- …eg protocol development, pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment + Support and input preparation ... the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions… more
- Takeda Pharmaceuticals (Lexington, MA)
- …use-safety engineering through Use-related Risk Analysis. + Developing Human Factors Validation Protocols and Reports. + Managing Human Factors, Industrial Design, ... Information Requests. + Developing Human Factors Summary Reports in compliance with FDA guidance. + Developing Usability Engineering Files in compliance with IEC and… more
- Catalent Pharma Solutions (Chelsea, MA)
- …consumer, and Catalent employee.** **The Role** + Provide support for validation , calibration, and preventative maintenance of all GMP equipment and systems; ... preferably in cGMP biopharmaceutical; pharmaceutical, medical device, food, or other FDA regulated industry; + Basic to moderate computer skills - including… more
- Integra LifeSciences (Mansfield, MA)
- …+ Works in accordance with all requirements for manufacturing medical devices (eg FDA QSR, ISO 9000, ISO 13485). + Completes required documentation as required by ... times. + Partners with engineering team to ensure completion of expansion & validation activities in a timely manner, acting as subject matter expert where… more
- Mentor Technical Group (Boston, MA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... interoperability. + Ensure data quality, accuracy, and integrity through robust validation and monitoring practices. + Manage data sources across categories such… more
- Abbott (Westford, MA)
- …program compliance with Quality Control requirements (ie Design Control, Process validation etc.). + Understand IP issues relative to processes being developed. ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more