QA Product Lead, Visp e/v/e/r/y/o/n/e
Core
Lead technical quality assurance for pharmaceutical injectable treatments, ensuring GMP compliance and regulatory adherence across product lifecycles.
Role type
Senior QA Product Lead (Pharmaceutical Manufacturing)
Builds
Injectable treatments for patients
Domain
Pharmaceutical industry, sterile manufacturing, GMP
Required skills
GMP compliance, sterile pharmaceutical production, aseptic operations, batch record review, regulatory submissions, quality agreements, method transfer, qualification and validation, technical documentation generation
Preferred skills
Microbiology, QC, drug product manufacturing
Technologies
GMP, CAPA, CR, SOPs, Master Batch Records
Responsibilities
Act as primary technical QA representative for customer projects; oversee quality throughout project phases; review and assess product quality records; execute quality agreements; support method transfer and validation activities; issue and review batch records; serve as SME during audits and inspections; support regulatory submissions; coordinate batch manufacturing and QC release; generate and approve critical technical documentation.
Seniority
Senior, hands-on IC
