Officer, Quality Control (Amneal pharma)

Roles and Responsibilities

Essential Functions:

• Perform testing of in process, finished product and stability analysis as per approved specifications, SOPs, and pharmacopeial methods (USP, EP,JP, etc.).

• To operate the instrument like HPLC, GC, UV, IR , dissolution and karl fischer .

• Ensure accurate and timely recording of results in logbooks, worksheets, and LIMS as per Good Documentation Practices (GDP).

• Adhere to cGMP, GLP, and safety protocols during sample handling, testing, and equipment usage.

• Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor

• Performing qualification, periodic calibration, and maintenance of laboratory instruments.

• Maintain proper cleanliness, calibration, and qualification status of analytical instruments.

• Ensure proper labeling, storage, and disposal of samples and reference standards.

Qualifications

Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 1 year or more in 1 - 4 Years

Specialized Knowledge: Licenses:

Required Skills

• Analytical Data Evaluation

• Analytical Testing & Evaluation

• Chemical Testing and Analysis

• Data Integrity & Documentation Security

• Documentation & Record Control

• Equipment Cleaning & Maintenance

• Good Documentation Practices (GDP)

• Laboratory Safety

• Sample Preparation Techniques

• Technical Documentation