The Senior Quality Specialist provides input into achieving Quality deliverables and ensures the site meets all Manufacturer’s License requirements for clinical and commercial production
Job Summary
The Senior Quality Specialist provides input into achieving Quality deliverables and ensures the site meets all Manufacturer’s License requirements for clinical and commercial production.
Responsibilities include application of Quality Risk Management, production support, documentation review, raw material release, and deviation management.
This role involves delivering on system improvements, participating in audits, and leading/participating in quality and site projects, including New Product Introduction.
Matching Summary
The Senior Quality Specialist provides input into achieving Quality deliverables and ensures the site meets all Manufacturer’s License requirements for clinical and commercial production.
Skills & Requirements
Must-have
cGMP Regulations
Deviation Investigations
GMP Compliance
Quality Assurance (QA)
Pharmaceutical Quality Assurance
Quality Management Standards
Nice-to-have
Lean / Continuous Improvement
Project Management
Facility Qualification
High potency manufacturing
Spray drying
Laboratory GMP
Key Requirements
Degree or post-graduate qualification in Science, Pharmacy or equivalent
Eligible to act as a Qualified Person, desirable but not essential
Experience in High potency manufacturing / Spray drying / Laboratory GMP / Project Management is desirable
Experience and knowledge of GMP Requirements for Electronic/paper free operations