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Job Summary
Inizio Engage is seeking a highly experienced Quality Assurance Lead Auditor to join their team. As a key member of the QA team, you will be responsible for managing the audit schedule, training internal auditors, and generating SOPs relevant to the position.
Key Responsibilities:
- Manage the audit schedule and ensure timely completion of internal audits and self-inspections.
- Train internal auditors or arrange appropriate training to ensure they are equipped to conduct audits effectively.
- Develop and review SOPs relevant to the position, ensuring they are up-to-date and compliant with regulatory requirements.
- Manage QPulse, the audit management system, to ensure accurate scheduling and tracking of audit non-conformances.
Requirements:
- Proven track record of QA internal/external auditing in the pharmaceutical or biotechnology industry.
- Lead auditor experience in GMP areas, with a strong understanding of regulatory requirements.
- Inspection experience with FDA, MHRA, and other agencies, with a focus on ensuring compliance.
About Inizio Engage
Inizio Engage is a rapidly expanding company in the pharmaceutical and biotechnology industry. As a leader in this field, we are committed to delivering high-quality products and services that meet the needs of our customers. We are seeking a highly experienced Quality Assurance Lead Auditor to join our team and contribute to our success.
