Gmp requirements for electronic/paper free operations
Quality risk management application
Production support and quality compliance
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This job posting is for a Senior Quality Assurance Specialist at Imsapharma Com Ar, focusing on maintaining and improving quality standards in drug substance and product facilities. The role involves leadership in quality compliance, risk management, documentation, and support for internal and external audits.
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Job Summary
The Senior Quality Specialist provides input into achieving Quality deliverables and ensures the site meets Manufacturer’s License requirements for clinical and commercial production.
This role involves ensuring timely and effective completion of Quality core functions, including application of Quality Risk Management and production support to meet GMP requirements.
The position requires participation in internal and external audits, system improvements, and leading/participating in Quality and site projects, including New Product Introduction.
Matching Summary
Match Score: 75
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This job posting is for a Senior Quality Assurance Specialist at Imsapharma Com Ar, focusing on maintaining and improving quality standards in drug substance and product facilities. The role involves leadership in quality compliance, risk management, documentation, and support for internal and external audits.
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Skills & Requirements
Must-have
GMP requirements for Electronic/paper free operations
Quality Risk Management application
Production support and quality compliance
Documentation preparation, review & approval
Deviation management process
Change controls documentation and assessment
Nice-to-have
Knowledge of Quality IT systems
Lean / Continuous Improvement expertise
Proven Leadership Skills
High potency manufacturing experience
Spray drying experience
Laboratory GMP experience
Project Management experience
Facility Qualification experience
Key Requirements
Degree or post-graduate qualification in Science, Pharmacy or equivalent