Senior Specialist - Quality Assurance (Night shift)
Core
Deliver QA leadership and oversight for aseptic manufacturing and packaging operations on the night shift, ensuring GMP compliance and patient safety.
Role type
Senior Specialist Quality Assurance (Aseptic Manufacturing)
Builds
Sterile pharmaceutical products
Domain
Pharmaceutical manufacturing / Aseptic processing
Required skills
GMP compliance, aseptic processing, cleanroom standards, deviation management, CAPA, data integrity, change control, quality risk management, coaching
Preferred skills
Microbiology, environmental monitoring, FMEA, HACCP
Technologies
EU GMP Annex 1, ICH Q9/Q10
Responsibilities
Provide technical guidance on cleanroom standards and aseptic techniques; Advise on deviations and lead root cause analysis; Support product release activities; Coach manufacturing personnel on cGMP and contamination control; Identify compliance risks and drive continuous improvement; Lead or support change controls.
Seniority
Senior, hands-on IC