Summary
The job involves conducting quality system and GMP compliance audits of suppliers in various industries, including Pharmaceutical and Cosmetics. The candidate must have strong QMS/GMP Auditing experience, be familiar with relevant regulations, and have excellent English communication skills. The position is on a contract basis, with travel to various supplier locations covered by the company.
Requirements
- Familiarity with pharmaceutical or related manufacturing processes
- Thorough familiarity with GMP/cGMP regulations (e.g. FDA cGMPs, ICH, IPEC, etcβ¦)
- 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 (21 CFR part 210/211, 21 CFR part 820, 21 CFR part 11, 21 CFR part 58), Eudralex vol. 4, Canada GMP, ICH Q7 β Active Pharmaceutical Ingredients / APIs, IPEC Excipient GMPs, IPEC GDP, ISO 13485, ISO 17025, ISO 9001, WHO Guidelines, and Other international GMP guidelines
- Strong English communication skills, both written and verbal
Responsibilities
Perform Quality System and GMP compliance Audits of Suppliers to the Pharmaceutical or Cosmetics manufacturing industries
Benefits
- Travel to various supplier locations is covered by SQA Services with approval
- The position is on a contract basis where you are paid per audit. The pay range for a one day audit that includes preparation, the audit itself, and the report is $1000-$1200