PharPoint Research, Inc. · 2 days ago
Quality Assurance Auditor
Wonder how qualified you are to the job?
Insider Connection @PharPoint Research, Inc.
Responsibilities
Assist with maintaining the Quality Management System (QMS) in line with regulatory requirements.
Generate and review SOPs, guidance, forms, and templates.
Conduct vendor audits and internal audits.
Assist in external audits and regulatory inspections.
Manage quality events, CAPAs, and deviations.
Participate in computer system validation and change control activities.
Interface with clients, stakeholders, and vendors.
Adhere to the company's Quality Management System and data integrity requirements.
Perform other related duties as assigned.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Bachelor’s degree (B.A./B.S.) or equivalent in a scientific, computer, or related discipline
Minimum 1-2 years’ experience in quality assurance, quality control, and/or validation
Knowledge and understanding of ICH Guidelines for Good Clinical Practice, Title 21 of the Code of Federal Regulations, and good industry practices involving Quality
Ability to read, write, speak and understand English
Preferred
Advanced degree or technical certification(s)
Computer system validation experience
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above