• Oversee the internal and supplier auditing program. Responsibilities include development of an annual schedule, coordinating internal and supplier audits, and reporting on internal and supplier audit schedule adherence. • Support external audits (regulatory bodies and client audits) on an as need basis. Responsibilities may include Hosting external audit and/or coordinating the war room activities. • Management and approval of Quality agreements and drafting Annual Product reviews as required. • Responsible for tracking metrics for the Quality department and presenting to management.
Understanding of Good Manufacturing and Laboratory Practices, FDA regulations, SOPs, and current compliance standards.• Ability to audit documents, procedures, and records for accuracy and continuity• This position requires a Bachelor's degree in life sciences, or equivalent experience Relevant Work Experience: 3-5 years' experience in the pharmaceutical industry
Source: Job Diva – Job Listing