Assistant Manager / Deputy Manager - IPQA
This role at Amneal Pharmaceuticals focuses on maintaining GxP and GMP compliance within pharmaceutical manufacturing and packaging environments. Responsibilities include conducting line clearances, managing batch record reviews, handling deviations, and performing impact assessments for quality notifications. The candidate will oversee environmental monitoring, calibration of IPQA instruments, and document archiving. This position requires deep expertise in quality assurance processes and regulatory readiness for major international audits.
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Experience
7-9 years
Function
Quality Assurance
Work mode
Onsite, India
Company
Tier 2
What you will work on
This role at Amneal Pharmaceuticals focuses on maintaining GxP and GMP compliance within pharmaceutical manufacturing and packaging environments. Responsibilities include conducting line clearances, managing batch record reviews, handling deviations, and performing impact assessments for quality notifications. The candidate will oversee environmental monitoring, calibration of IPQA instruments, and document archiving. This position requires deep expertise in quality assurance processes and regulatory readiness for major international audits.
Must haves
- 7-9 years of experience in IPQA functions
- Proficiency in GxP and GMP compliance
- Advanced knowledge in batch record review
- Experience with change control and deviation management
- Expertise in internal audits and regulatory readiness
Tools and skills
Nice to have: usfda regulatory inspection readiness, ema regulatory inspection readiness, mhra regulatory inspection readiness, eugmp regulatory inspection readiness, who regulatory inspection readiness.
About the company
Established pharmaceutical company with international operations.