Associate GMP Compliance Auditor (m/w/d)

Associate GMP Compliance Auditor (m/w/d)

Carryout job duties under guidance of management and/or designee, including the planning and scheduling of third-party supplier audits.

Support the planning and conduct of paper-based quality assessments of third-party suppliers (e.g., Quality Questionnaires, Quality History).

Support the maintaining of approved supplier list, global audit schedule, and participation in supplier management processes.

Gathers internal and external audit metrics and presents to QA management for trend analysis.

Assist External Partners Quality management on the collaboration with Inspection Management group on external party audits by regulatory agencies or customers.

Assist senior auditors and management to develop, maintain and update departmental systems, procedures, and records pertinent to position responsibilities.

Expected to elevate any issues to management, as necessary, in meeting these responsibilities.

Support group goals, with possibility of leading departmental level goals. Resolves project team issues with minimal oversight.

Prepare and present project progress reports to update management and keep the team(s) informed.

Bachelor’s degree preferable in a physical science, life science, pharmacy, business, engineering or equivalent experience required.

0-2 years experience in function or related fields, such as:

• Basic understanding of cGMP regulatory standards
• Laboratory and/or Pharma/Device Manufacturing
• Quality Assurance/Regulatory Affairs
• Pharmaceutical/Healthcare Industry

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.