Quality Auditor - Pharmaceutical

SQA Services is a leading Quality Assurance and Supply Chain consultancy firm. SQA manages Supplier Audit and Supplier Development programs for customers in many industries including Pharmaceutical, Medical Device, Automotive, Aerospace, and Electronics manufacturing. Clients leverage SQA’s network of Quality Professionals in more than 50 countries as an extension of their own Supplier Quality teams.

Job Title: Quality Auditor / GMP Auditor

Description and Requirements:

Auditor will be responsible for performing Quality System and GMP compliance Audits of Suppliers to the Pharmaceutical or Cosmetics manufacturing industries. The overall goal of SQA’s Supplier Audit programs is to mitigate risk across our customers’ supply chains. Supplier Audits typically last 1-3 days on-site not including audit report generation.

The right candidate must be familiar with pharmaceutical or related manufacturing processes and be thoroughly familiar with GMP/cGMP regulations (e.g. FDA cGMPs, ICH, IPEC, etc…). The auditor must have strong QMS/GMP Auditing experience having conducted many Supplier or External audits throughout his or her career.

Relevant quality standards and audit types include, but are not limited to

· FDA Regulations:

o 21 CFR part 210/211 (current Good Manufacturing Practice for Pharmaceuticals)

o 21 CFR part 820 (Medical Devices)

o 21 CFR part 11 (Electronic Records)

o 21 CFR part 58 (Good Laboratory Practices)

· Eudralex vol. 4

· Canada GMP

· ICH Q7 – Active Pharmaceutical Ingredients / APIs

· IPEC Excipient GMPs

· IPEC GDP

· ISO 13485

· ISO 17025

· ISO 9001

· WHO Guidelines

· Other international GMP guidelines

The Quality Auditor must have strong English communication skills, both written and verbal. Auditor will work directly with SQA Services headquarters personnel in Los Angeles, USA, but can be located anywhere in the world.

This job is done on a contract basis where you are paid per audit. This position requires travel to various supplier locations. All travel and expenses are covered by SQA Services with approval.

Required: IPEC Excipient GMPs, ICH Q7, 21 CFR Part 210/211 auditors local within state (OH, IN, IL).