Filling Line Lead
Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA...
Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA...
to other staff members. Scan appropriate documents into EMA. Verify insurance benefits and eligibility. Collect outstanding...
satisfaction objectives. Build and maintain relationships with senior stakeholders, including regulatory agencies (e.g., FDA, EMA...
, Smartsheet, etc.). Working knowledge of ICH-GCP and applicable regulatory requirements (FDA/EMA). Strong organizational...
Systems;3–5 years leadership. Recent pharmaceutical manufacturing experience is required. Strong knowledge of FDA/EMA...
pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules...
filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA). Leadership: Establish...
with multiple agencies (FDA, EMA, JNDA, TGA). Leadership: Support Cell Culture CMC teams, and align resources to deliver...
, and regulatory requirements such as EMA and MHRA) and industry best practices (e.g., CDISC Trial Master File Reference Model... and regulatory inspections (e.g., FDA, PMDA, EMA, MHRA). Thorough understanding of ICH- GCP guidelines and regulatory requirements...
Medical Technicians – Paramedic Certification, preferred EMA/NIMS ICS certifications, preferred. Other: Excellent oral...