GMP Auditor

Pharmazone; Bhadaj; On-site; INR 600,000 - 900,000; Full time

Job summary

Pharmazone is seeking a regulatory compliance auditor to conduct GMP audits, gap analyses, and CAPA reviews for API, excipients, packaging materials, and testing labs in India. The role involves preparing technical regulatory documents, supporting validation/qualification activities, and delivering training to site teams.

Ideal candidates will have a B.Pharm/M.Pharm/M.Sc with 4-5 years of GMP auditing experience and strong knowledge of USFDA/EMA/PICS/WHO standards, plus excellent communication

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.
• B. Pharm. / M. Pharm. / M.Sc.

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.

Skills

Analytical skills

Problem-solving

Written & verbal communication

Attention to detail

Independent work

Education

B. Pharm.

M. Pharm.

M.Sc.

Job description

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
• B. Pharm. / M. Pharm. / M.Sc.