. Responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training. Responsible... messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives...
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...
with cGMP, regulatory requirements (FDA, EMA), and quality assurance practices in medical device, drug-device systems... The benefits that you are eligible for with Collins Consulting, Inc: 401(k) Medical, Dental and Vision Insurance Term...
delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing...: In this position, you will be responsible the daily receiving, storage, and distribution activities for *CGT cGMP warehouse at the...
Trident Consulting is seeking a " Production Technician II " for one of our client in " Indianapolis, IN. A global... coursework preferred Minimum 3-5 years, including relevant aseptic filling experience in a cGMP pharmaceutical manufacturing...
processes, equipment, and systems comply with cGMP, aseptic processing requirements, and global regulatory expectations. Author... experience applying and maintaining cGMP compliance within aseptic DP operations, including participation in regulatory...
of 10 years experience in aseptic drug product compounding in a biotherapeutics cGMP environment (preferably in process... facility/equipment design Solid understanding of the following : cGMP's for biotherapeutics DP aseptic compounding EHS...
, solvent recovery concepts) where they make valuable contributions Ensure API cGMP standards are applied consistently... understanding of reactor systems, solvent handling, and process analytical/controls as applicable Strong understanding of cGMP...
packaging of large-molecule, biotherapeutic products Solid understanding of the following: cGMP requirements.... Required Skills: Preferred Skills: Agile Decision Making, Coaching, Consulting, Corrective and Preventive Action (CAPA), Crisis...
equipment preparation area for a new cGMP drug product manufacturing plant. They will be responsible for leveraging... of the following: cGMP's for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the...