Quality Assurance Specialist - Pharmaceutical Manufacturing
Core
Ensuring pharmaceutical manufacturing processes and products meet stringent quality standards and regulatory requirements (GMP) in a hands-on manufacturing environment.
Role type
Quality Assurance Specialist (Pharmaceutical Manufacturing)
Builds
Pharmaceutical products
Domain
Pharmaceutical Manufacturing
Required skills
GMP compliance, internal auditing, deviation investigation, CAPA management, validation principles, change control, SOP development, regulatory inspection support, product release, batch record review
Preferred skills
MS Office, quality management software
Responsibilities
Review and approve batch manufacturing records; Conduct internal audits of manufacturing processes and quality systems; Investigate deviations, OOS results, and customer complaints; Participate in equipment and process qualification; Develop and implement SOPs; Monitor key quality indicators; Manage change control processes; Support external regulatory inspections; Train manufacturing personnel on GMP; Release finished products.
Seniority
Mid-level, hands-on IC
