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
Aseptic manufacturing and packaging operations
Domain
Pharmaceutical manufacturing / Aseptic processing
Required skills
GMP knowledge, EU GMP Annex 1 expertise, aseptic processing knowledge, cleanroom compliance, deviation and CAPA management, product release support, change control, quality risk management, data integrity, coaching and influencing
Preferred skills
Microbiology experience, environmental monitoring, sterility assurance concepts, 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