Quality Engineer
Hubot | Tri Pac, Inc. CDMO is seeking a senior quality engineer to support U.S.-regulated manufacturing operations from India. The role focuses on driving quality excellence, leading investigations, and maintaining eQMS platforms. Candidates must have extensive experience in GMP environments and proficiency with regulatory standards like FDA 21 CFR Part 11. This role involves collaboration with cross-functional global teams to ensure adherence to global quality metrics.
50k new jobs listed every day. Install TAL to find more jobs like this.
Experience
5+ years
Function
Quality Assurance
Work mode
Remote, India
Company
Tier 2
What you will work on
Hubot | Tri Pac, Inc. CDMO is seeking a senior quality engineer to support U.S.-regulated manufacturing operations from India. The role focuses on driving quality excellence, leading investigations, and maintaining eQMS platforms. Candidates must have extensive experience in GMP environments and proficiency with regulatory standards like FDA 21 CFR Part 11. This role involves collaboration with cross-functional global teams to ensure adherence to global quality metrics.
TAL's take
Solid defined role in a regulated industry with clear technical requirements and remote flexibility.
The JD provides a highly detailed list of responsibilities and technical expectations within a specific manufacturing compliance domain.
Must haves
- 5 years experience in GMP-regulated environment
- Understanding of FDA regulations and ISO standards
- Hands-on experience with eQMS platforms
- Experience with root cause analysis and CAPA
- BA/BS degree in Engineering, Quality, or Life Sciences
Tools and skills
About the company
Established CDMO operating globally with specialized pharmaceutical and manufacturing focus.