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
- Solid 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.