aligned with FDA, EMA, and MHRA expectations, including EU GMP Annex 1 & 11, 21 CFR Parts 11/210/211/820, ISO 13485, GAMP 5... or biologics manufacturing environments Hands-on experience hosting FDA, EMA, and/or MHRA inspections and client audits...
, and processes comply with regulatory standards (FDA, EMA, ISO, GMP, GDP) and internal quality policies. The Quality Assurance... requirements. Ensure compliance with FDA, EMA, ICH, and other relevant regulatory bodies for pharmaceutical and life sciences...
demonstrated experience with Change Control and Risk Management. Experience in FDA/EMA regulations in biopharmaceuticals or cell...
to ensure smooth product development and commercialization. Regulatory Compliance: Ensure all processes comply with FDA, EMA...
with FDA, EMA, and ICH guidelines for pharmaceutical manufacturing. Data Analysis & Reporting: Analyze process data, identify...
office equipped with updated technology and EMA software Position available due to strong patient demand and practice growth...
with EMA / EMR software. Position Highlights Full-time Dermatology Nurse Practitioner or Physician Assistant role General..., experienced team with strong support staff Modern clinic with EMA / EMR for efficient workflow Competitive salary...
base (30+ per day) Collaborative, experienced team with strong support staff Modern clinic with EMA/EMR Compensation...
datasets. Prepare submission artifacts (reviewer's guides, Define.xml, annotated CRFs) aligned with FDA/EMA expectations...
, FDA, and EMA standards. The Manager will effectively communicate results and issues to peers and management with excellent... analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards Manage/validate SLIMstat software...