Officer, Quality Assurance
Actively Reviewing the ApplicationsAmneal Pharmaceuticals
India
Full-Time
On-site
Posted 2 months ago
•
Apply by April 28, 2026
Job Description
Job Description
JOB DESCRIPTION
The Officer – IPQA is responsible for performing in-process quality assurance activities during API manufacturing operations in compliance with cGMP requirements. The officer ensures proper line clearance, equipment cleaning verification, and adherence to GMP and safety practices on the shop floor
Key Responsibilities
QUALIFICATIONS
JOB DESCRIPTION
The Officer – IPQA is responsible for performing in-process quality assurance activities during API manufacturing operations in compliance with cGMP requirements. The officer ensures proper line clearance, equipment cleaning verification, and adherence to GMP and safety practices on the shop floor
Key Responsibilities
- Perform in-process quality assurance (IPQA) activities for API manufacturing as per cGMP requirements.
- Monitor critical process parameters, sampling activities, and in-process controls on the shop floor.
- Review and verification of batch manufacturing records (BMRs), logbooks, and production documents.
- Ensure compliance with SOPs, GMP, safety, and data integrity practices.
- Handling and documentation of deviations, OOS/OOT, change controls, and CAPA in coordination with cross-functional teams.
- Support internal, external, customer, and regulatory audits; ensure timely closure of audit observations.
- Verification of equipment cleaning, line clearance, and process adherence.
- Coordination with Production, QC, Engineering, and EHS teams for quality-related issues.
- Strong understanding of API manufacturing processes and IPQA controls.
- Excellent documentation and compliance skills.
- Good communication and coordination abilities.
- Attention to detail and problem-solving mindset.
- Ability to work in shifts and handle shop-floor QA activities.
QUALIFICATIONS
- M.Sc. in Chemistry (mandatory).
- Sound knowledge of cGMP, ICH guidelines, and API regulatory requirements.
Required Skills
Quick Tip
Customize your resume and cover letter to highlight relevant skills for this position to increase your chances of getting hired.
Related Similar Jobs
View All
Data Centre Engineering Operations, Data Center Engineering Operations
Amazon Web Services (AWS)
India
Full-Time
Engineering
Mechanical Engineering
Electrical Engineering
+3
Senior Data Scientist
SynapOne
India
Full-Time
Communication
Engineering
Data Analysis
+36
Senior Data Engineer
Commonwealth Bank
India
Full-Time
Communication
Engineering
Troubleshooting
+89
Database Engineer
Amazon
India
Full-Time
Engineering
MySQL
PostgreSQL
+35
Lead Engineer, Quality Engineering
LSEG
India
Full-Time
Python
Financial markets
Regression
+2
Quick Apply
Upload your resume to apply for this position