QUALITY ASSURANCE PROCEDURES

I was responsible for review of SOPs and other quality assurance related technical data forms and
quality documents, with maintenance of control documents and review of validation protocols for
GMP compliance. I also undertook internal quality audits on company systems and documentations
and performed investigations on non-conformances while developing the required corrective actions
Audit on-going vendors, systems and documents to assure quality assurance compliance with regard to
all internal procedures as well as regulatory guidelines
Provide GCP/ QA support and avdvice to internal and external clients
Ensure the timely and effective follow up to all identified or assigned quality issues
Maintains and demonstrates understanding of global standards, regulation and regulatory bodies to
include but not limited to ISO13485, 21FR; part 820 AIMD
Assist in the maintenance ogf Quality Management System under direction of Director, Quality
Assurance