Join Our Growing Team
Regula is seeking highly competent and experienced GXP auditors for its growing team.
Job Summary:
The successful candidate will be responsible for preparing, conducting, reporting GXP related Audits such as API, Excipient, Packaging Material Manufacturer & Supplier, Sterile/ Non-Sterile Medicinal Product Manufacturing Facilities, Data Integrity, Good Distribution Practices & Good Storage Practices according to Local and International Guidelines and Directives (FDA, EMA, MHRA, PIC/S, ICH, TMMDA etc.)
Ideal candidates should have some distinguished qualifications:
- Bachelor’s degree in Chemistry, Chemical Engineering, Biology, Pharmacy or closely related science from a four-year college/university.
- At least 10 years of GXP and 5 years of auditing experience (FDA, MHRA, PIC/S, ICH, EMA, TMMDA)
- In-depth knowledge of Pharmaceutical, Biopharmaceutical regulations: GMP, GDP, GQCLP, GCP and Health regulations (ICH, FDA, EU, main local regulations, ISO …etc)
- Excellent written and verbal communications skills in English
- Good communication and organizational skills
- Good time management skills
- The ability to work well on a team as well as independently
- Conducting inspection readiness visits at selected client sites (as applicable) to assess inspection risk
- Ability to enter into highly different cultural and regulatory backgrounds worldwide
- Ability to present audit findings in a clear, concise and diplomatic way to all levels of Management.
- Conduct mock interviews for subject matter experts (SMEs) during inspection preparation
- Ready to travel 50-75 % of time
- Reviewing, and analyzing regulatory inspection data issued by regulatory authorities (e.g. MHRA, EMA, FDA, PIC/S, TMMDA)
Preferred Qualifications:
- IRCA or Equivalent Certificated Auditor / Lead Auditor
- MSc and/ or Ph.D in related field
- Experience with Risk Assessment, Controls and Management.
Recruitment Process:
We look forward to receiving your application with your recent CV and cover letter including your salary expectations.
A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.
