Audit Professional - GMP

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.