...in a regulated environment. They will be responsible for overseeing the company's manufacturing operations, ensuring compliance with FDA regulations, and leading strategic planning initiatives. This position offers a unique opportunity to be a part of a dynamic team that...
...equipment suppliers and specifying equipment needs
Ensuring that all regulatory requirements are met, including HIPAA, OSHA, and FDA regulations
Coordinating meetings with other staff members to ensure that everyone is on the same page about project details
Preparing...
...related to quality management and packaging manufacturing.
Ensure compliance with relevant regulatory requirements such as ISO FDA and customerspecific standards.
Requirements
Bachelor s degree in Engineering Quality Management or a related field....
...computer software, such as Microsoft applications.
~ Expert knowledge of cGMP regulations.
~ Expert knowledge and understanding of FDA policies and regulations.
~10+ years of management experience in a pharmaceutical manufacturing setting.
~ Pharmaceutical...
...design and/or protocol management.
Clinical trial monitoring procedures and clinical data reporting processes.
ICH GCP guidance and FDA regulations.
Medical terminology and anatomy/physiology.
Microsoft Suite of software products.
Intermediate project...
...Technical, and Professional Fields Qualified and Outstanding Candidates
Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and...
...Execution focused, driven team: Join a team with an incredible record - we are the smallest, fastest company in history to receive FDA hematology clearance. We are also the largest Remote Patient Monitoring company in the US, with a fast-growing SaaS Revenue Cycle Management...
...formulations.
Experience with analysis of active pharmaceutical ingredients (API) and their process development.
Awareness with FDA/EU/UK and ICH regulations and guidances related to analytical transfer and validation and release and stability testing.
Working...
...Developing systems for auditing processing facility activities
Planning, preparation, and participation in accreditation reviews (FACT & FDA (Food and Drug Administration))
Ultimate responsibility for the development of a comprehensive quality management plan and proper...
...compliance for the location leadership team.
~5% Complete all required audits in collaboration including the following but not limited to, FDA (Food & Drug Administration), WDATCP (Wisconsin Department of Agriculture, Trade & Consumer Protection), USDA (United States...
...discrepancies, and address BOM issues.
Manage responsibilities across the entire project lifecycle, from concept and prototyping to FDA approval and commercialization. Set testing requirements and parameters to meet quality standards.
Advanced proficiency in Excel is...
...initial informed consent and throughout all phases of study discusses study details with the participant in accordance with ICH and FDA guidelines
Performs study-related tasks and procedures, such as investigational product administration, phlebotomy, urine collections...
...GMP approval from highly regulated authorities (HRAs) USFDA/MHRA/EU/TGA.
Solid track-record in Managing Quality System and handling FDA's inspections.
Must be highly organized, self-motivated and experience in building or updating quality system for Pharmaceuticals...
...monitor cardiac and respiratory disease by bringing together advanced sensors, patient and provider software, and AI-powered analysis. Its FDA cleared platform is used by tens of thousands of clinicians treating millions of patients around the world, in-person, and through...
...Clinical, and Suvoda
~ Prior experience working with multiple Clinical Information Systems simultaneously.
~ General knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA Google Cloud Platform guidelines
~...
...Engineering Required (Mechanical, Industrial, Electrical, or Computer degrees are preferred) 2+ years Engineering / Manufacturing experience. FDA manufacturing preferred. Programming/troubleshooting experience with automation controls, automated assembly, control systems, PLC s,...
...Compliance:
Ensure that mechanical designs comply with relevant industry standards and regulatory requirements such as ISO ASTM and FDA regulations.
Collaborate with regulatory affairs team to prepare documentation and submissions for regulatory approvals as needed....
...for automated clinical assessment of Parkinson's disease. Recently, the technology was awarded Breakthrough Device Designation by the FDA. In addition, Machine Medicine is a scientifically productive and technically ambitious entity. We have published papers in numerous...
...Bone marrow transplant director, quality assurance and physicians.
Assist in maintaining accurate documentation in compliance with FDA's Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices regulations as well as standards set by other...
...Requirements
Bachelors degree in business, supply chain or related field Masters degree preferred
Supervised 25 or more associates in an FDA controlled, SQF or cGMP production environment
Experience in the medical cannabis industry not required, but a plus
A high-...
...the client with a very limited time (shelf life, GTIN, Barcode, ..etc) from sales/procurement team or from principal company website/ FDA certificates and other global associations.
REQUIREMENTS
Candidates need to be Arabic speakers due to the nature of the job...
...verbal and written)
Ability to maintain current knowledge of Cellular Therapy and Cord Blood regulations and standards – AABB, FACT, FDA, NMDP, etc.
Ability to supervise, train, and review training and competency assessment.
Ability in writing Cord Blood & CT...
...Execution focused, driven team: Join a team with an incredible record - we are the smallest, fastest company in history to receive FDA hematology clearance. We are also the largest Remote Patient Monitoring company in the US, with a fast-growing SaaS Revenue Cycle Management...
...understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO).
Actively engaged in major industry associations (e.g. CPC, EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and...
...will also have opportunities to participate in scientific publications and conferences and the opportunity to turn your ideas into CE / FDA-cleared products aiming to help detect cancer early.
Requirements:
Masters or PhD in Computer Science / Machine Learning or...
...chemicals and disinfectants used in conjunction with your hygiene duties
~ Be fully conversant with the requirements of both the MCA and FDA with respect to Good Manufacturing Practice and hygiene standards
~ Carry out all hygiene tasks in accordance with written approved...
...equipment suppliers and specifying equipment needs
Ensuring that all regulatory requirements are met, including HIPAA, OSHA, and FDA regulations
Coordinating meetings with other staff members to ensure that everyone is on the same page about project details
Preparing...
...knowledge of food chemistry, microbiology and processing techniques.
Familiarity with industry legislation and quality standards (e.g., FDA, HACCP, GMP).
Experience in sensory evaluation and consumer testing methods.
Excellent problem-solving and analytical skills....
...manipulation, pushing and pulling.
~ Work requires the following motions: bending, twisting, squatting and reaching.
~ Exposure to FDA approved cleaning chemicals.
~ Exposure to temperatures: Less than 32 degrees Fahrenheit (freezing), 32-40 degrees Fahrenheit (...
Business Development Officer - Medical Diagnostics Division - Invention Vision Medical Requisit[...]
...instruments and reagents which meet the highest international quality production standards including ISO 9001:2015 EN 46001 and ISO27799 US FDA CE IVD.
We have been in this business for 08 years now having customers across GCC countries like UAE Oman Saudi Arabia. Our...