QA Operations Expert (m/f/d)
Core
Provide hands-on quality oversight for Drug Product manufacturing, ensuring compliance with regulatory standards and GMP to safeguard patient safety.
Role type
Senior IC Quality Assurance Operations Expert
Builds
Drug Product manufacturing batches and compliant supply
Domain
Pharmaceutical manufacturing / Good Manufacturing Practice (GMP)
Required skills
GMP compliance, deviation investigation, batch release, regulatory standards, change management, audit support, technical documentation review, process validation, specification approval, root cause analysis
Preferred skills
Batch release activities, packaging materials, drug substance, drug product manufacturing
Technologies
QMS, SPC, AMBO
Responsibilities
Lead and approve deviation and out-of-expectation investigations; Release incoming DS and internally produced bulk batches; Review and approve manufacturing, quality control, and technical documentation; Approve manufacturing records and quality documentation; Support transfer of new products to commercial manufacturing sites; Participate in internal and external audits.
Seniority
Mid-level, hands-on IC
