Regula is seeking highly competent and experienced GXP auditors for its growing team.
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)
- IRCA or Equivalent Certificated Auditor / Lead Auditor
- MSc and/ or Ph.D in related field
- Experience with Risk Assessment, Controls and Management.
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.