Company Description

Pharmazone is a renowned consulting firm in the Pharmaceutical & Life Sciences sector, trusted for its expertise and commitment. Specializing in Regulatory Affairs, Pharmacovigilance, and GxP Compliance, we offer tailored solutions through our unique Commit-Collaborate-Carry Model, aimed at enhancing patient outcomes.

Our Regulatory Specialists provide a range of services including Regulatory Intelligence & Strategy, Medical Writing, Submission & Publishing, and Pharmacovigilance support. We assist companies of all sizes in executing drug development plans and meeting post-approval requirements for regulated markets and beyond.

With a dynamic global Regulatory Landscape, our GXP compliance services are indispensable for clients. Our expertise in GMP Auditing & Consulting, Clinical Monitoring, and GMP Solutions has earned us recognition and numerous awards, reflecting our dedication to excellence.

At Pharmazone, our mantra of "Value Creation by Right Solutions" drives our commitment to client satisfaction. With a proven track record and a team spanning key global locations, we are poised to deliver exceptional service to our clients worldwide.

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

• GMP auditing experience 4-5 Years
• 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