GMP Compliance Auditor
2 weeks ago
SQA Services is a prominent consultancy specializing in Quality Assurance and Supply Chain management. We provide comprehensive Supplier Audit and Development programs across various sectors, including Pharmaceuticals, Medical Devices, Automotive, Aerospace, and Electronics manufacturing.
Our clients benefit from SQA's extensive network of Quality Professionals operating in over 50 countries, acting as an extension of their Supplier Quality teams.
Position Title:Quality Auditor / GMP Auditor
Role Summary:The Quality Auditor will be tasked with conducting audits focused on Quality Systems and GMP compliance for Suppliers within the Pharmaceutical or Cosmetics manufacturing sectors. The primary objective of SQA's Supplier Audit initiatives is to minimize risks throughout our clients' supply chains.
Audits generally require 1-3 days on-site, excluding the time needed for report preparation. The ideal candidate should possess a solid understanding of pharmaceutical manufacturing processes and be well-versed in GMP/cGMP regulations, including but not limited to FDA cGMPs, ICH, and IPEC standards.
Key Responsibilities:- Conduct Supplier or External audits, ensuring adherence to relevant quality standards.
- Familiarity with FDA Regulations, including 21 CFR parts 210/211, 820, and 11.
- Understand international GMP guidelines such as Eudralex, Canada GMP, ICH Q7, and ISO standards.
The Quality Auditor must demonstrate exceptional English communication skills, both written and verbal.
This role involves collaboration with SQA Services personnel, with the flexibility to work remotely from any location. The position operates on a contract basis, with compensation provided per audit conducted. All travel and related expenses will be reimbursed by SQA Services upon approval.
The compensation for a one-day audit, which includes preparation, the audit itself, and report proofreading, ranges from $1000 to $1200.
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