cGMP Auditor

Synergy Bioscience is looking for a cGMP Auditor with good experience in auditing pharmaceutical manufacturing sites. In this role, you will be asked to work closely with the site management on developing and implementing a quality system gap assessment audit as part of preparing for an upcoming FDA inspection. You will also be asked to help the site management in drafting an action plan to address the audit findings and ensure the site's readiness for the upcoming regulatory inspection. This is a contract position that will last for at least one year.

As part of your role, you will:

• Develop the audit agenda and coordinate with the manufacturing site management.
• Lead the inspections and audits of the manufacturing facility to ensure compliance with the FDA and ICH requirements, by reviewing the current facility Quality Management System documentation, such as Work Instructions, policies, and procedures.
• Provide a detailed audit report with all the audit findings.
• Interact with senior leadership teams, cross-functional project teams, and external vendors/parties to ensure the audit findings are adequately addressed.
• Provide status of the project deliverables.
• Review the audit findings corrective/preventive action items implementation and approve them.
• Draft a closing audit summary report detailing how the findings were addressed by the site management.

Qualifications:

• Prior quality, compliance, and audit experience with a minimum of 5 years of audit experience.
• Must have knowledge and experience with cGMP manufacturing environment, as well as quality and regulatory compliance requirements per the US FDA 21 CFR 210 and 211.
• Experience with regulatory inspections and GMP audits
• Good writing and communication skills
• Ability to track projects' progress from start to finish
• Successful and creative negotiation of compliance issues with the site management.