GMP Auditor
2 days ago
Role Description
This is a full-time on-site role for an Auditor located in Ahmedabad. As an Auditor, you will be responsible for conducting GMP audits, study design audits, Compliance & Validation Audits, and audits for other compliance services. You will also provide quality consulting, USFDA/EMA/PICS/WHO accreditation support, CSV & engineering services, and assist in plant setup and upgradation. Additionally, you may be involved in program management and report library management.
Responsibilities
- Performing Gap analysis of the existing facilities with the required regulatory requirements for API / Excipients / Packaging Material companies / Testing Laboratories.
- Preparing report and CAPA review in timely manner
- Preparation of technical documents as per regulatory expectations.
- Providing Validation / Qualification Services.
- Imparting training to the employees/site team members
- To take part in remediation projects allotted by company.
Qualifications
- Knowledge of USFDA/EMA/PICS/WHO regulations and accreditation support
- Strong analytical and problem-solving skills
- Excellent written and verbal communication skills
- Attention to detail and ability to work independently
- Relevant certifications and qualifications in auditing and compliance preferred
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