Junior Manager / Assistant Manager - Global Quality GMP Auditor
STADA is seeking a GMP Auditor for its Global Quality team to conduct audits of specialty and biosimilar products. The role involves planning and executing audits for third-party manufacturers and suppliers to ensure compliance with EU GMP and FDA standards. The candidate will support risk management, inspection readiness, and cross-functional reporting across global regions. This is an audit-focused role requiring deep regulatory expertise in a pharmaceutical context.
50k new jobs listed every day. Install TAL to find more jobs like this.
Experience
8-10 years
Function
Quality Assurance
Work mode
Onsite, India
Company
Tier 2
What you will work on
STADA is seeking a GMP Auditor for its Global Quality team to conduct audits of specialty and biosimilar products. The role involves planning and executing audits for third-party manufacturers and suppliers to ensure compliance with EU GMP and FDA standards. The candidate will support risk management, inspection readiness, and cross-functional reporting across global regions. This is an audit-focused role requiring deep regulatory expertise in a pharmaceutical context.
TAL's take
Stable role at a large international pharmaceutical firm with clearly defined regulatory responsibilities and audit requirements.
The JD provides a highly detailed list of responsibilities, specific regulatory standards, and clear expectations for the GMP Auditor role.
Must haves
- Bachelor's degree in Pharmacy, Chemistry, or Biotechnology
- 8–10 years of experience in pharmaceutical or biopharmaceutical industry
- Hands-on experience in QA/QC, Production, or R&D
- Proven track record in auditing third-party manufacturers
- Strong knowledge of EU GMP, FDA, and ICH regulations
Tools and skills
Nice to have: pharmacovigilance, gcp.
About the company
Established international pharmaceutical company, but lacks the specific engineering prestige of top-tier global tech or major biotech firms.