Senior Specialist - Quality Assurance (Validation)
Core
Lead qualification and validation activities for equipment, utilities, facilities, processes, and computer systems in a pharmaceutical manufacturing environment to ensure regulatory compliance.
Role type
Senior Specialist - Quality Assurance (Validation)
Builds
Validated state of equipment, systems, and processes for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Qualification and validation principles, Protocol and report preparation, Risk assessment, Change control review, CAPA management, Validation Master Plan development, Regulatory guideline compliance, Cross-functional coordination
Preferred skills
Regulated industry experience, Pharmaceutical manufacturing environment experience
Technologies
Microsoft Word, Excel, Access, PowerPoint, Explorer
Responsibilities
Prepare and review qualification documents (DQ, IQ, OQ, PQ), Execute validation activities, Coordinate with cross-functional teams and external providers, Review change controls and perform risk assessments, Manage incidents and deviations, Write and review validation SOPs, Suggest continuous improvements to validation strategies
Seniority
Senior, hands-on IC