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Quality Assurance Auditor
2 months ago
SQA Services is a prominent consultancy specializing in Quality Assurance and Supply Chain management. We offer 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, serving as an extension of their Supplier Quality teams.
Position Title:Quality Auditor / GMP Auditor
Role Overview:The Auditor will be tasked with conducting Quality System and GMP compliance audits for Suppliers within the Pharmaceutical or Cosmetics manufacturing sectors. The primary objective of SQA's Supplier Audit programs is to minimize risks throughout our clients' supply chains.
Supplier Audits typically span 1-3 days on-site, excluding the time required for audit report generation. The ideal candidate should possess a solid understanding of pharmaceutical or related manufacturing processes and be well-versed in GMP/cGMP regulations (e.g., FDA cGMPs, ICH, IPEC, etc.).
Key Responsibilities:- Conduct thorough Supplier or External audits, leveraging extensive QMS/GMP auditing experience.
- Ensure compliance with relevant quality standards and regulations, including but 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 – Active Pharmaceutical Ingredients / APIs
- IPEC Excipient GMPs and GDP
- ISO 13485, ISO 17025, ISO 9001
- WHO Guidelines and other international GMP standards
The Quality Auditor must demonstrate strong English communication skills, both written and verbal.
Collaboration will occur directly with personnel from SQA Services headquarters, while the Auditor can operate from any global location.
This role is structured on a contract basis, with compensation provided per audit. Travel to various supplier sites is a requirement, with all travel and expenses covered by SQA Services upon approval.
The compensation range for a one-day audit, which includes preparation assistance, the audit itself, and report proofreading, is between $1000 and $1200.
