GMP Auditor

2 weeks ago

Ahmedabad, Gujarat, India Pharmazone Full time

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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