. Experience in cGxP and/or cGMP is required. Experience as an Owner’s Representative in Project Management on biopharmaceutical... in sustainable engineering, architecture, and environmental consulting. The diverse perspectives of our partners and interested...
that all activities within bulk drug substance operations adhere to cGMP and other regulatory requirements. Responsibilities: Provide... Development Laboratories. Ensure facilities, equipment, materials, processes, and products comply with cGMP standards...
, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the... of manufacturing and technology. Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing...
and understanding of cGMP, including FDA and EMEA. Demonstrated strong project leadership of cross-functional teams through project... Expenditures, Change Agility, Consulting, Cross-Functional Team Leadership, Engineering Principle, Engineering Standards...
within bulk drug substance operations adhere to cGMP and other regulatory requirements. Key Responsibilities: Provide quality... Development Laboratories. ○ Ensure facilities, equipment, materials, processes, and products comply with cGMP standards...
and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis... and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications: Bachelor...
of cGMP, sterile product packaging, and biologics/combination product considerations. Experience with packaging validation... or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents...
, and clinical research industries nationwide by providing calibration, commissioning and consulting solutions. At PCI, calibrations... are performed by highly technical, cGMP/GLP-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA...
activities may include reviewing documents and data, conducting basic floor audits and process inspections, consulting on quality..., and other documents and/or reports as needed. Complies with company polices and SOPs. Ensures timely completion and compliance with cGMP...
About Us We are a preeminent regulatory management consulting firm serving companies in the Food/Beverage, Dietary.../development, FSMA/HARPC Plan writing/reviews, cGMP Facility Audits as directed, safety data sheets, registrations in US markets...