Role & responsibilities

Key Responsibilities
Perform analysis of Raw Materials, In-process, Finished Products and Stability Samples as per approved specifications and test methods
Operate and handle analytical instruments such as HPLC, GC, UV, IR, KF, Dissolution and other laboratory equipment
Prepare and review analytical reports, raw data and GMP documentation
Ensure timely completion of analysis activities and compliance with release timelines
Handle OOS, OOT, deviations and support investigation activities
Ensure laboratory compliance with cGMP, GDP and data integrity requirements
Support method verification, transfer and validation activities
Prepare SOPs, specifications, protocols and laboratory records
Participate in audit preparation and regulatory inspections
Coordinate with Production,



QA and cross-functional teams for analytical support

• Ensure adherence to safety and quality procedures

Skills Required: Hands-on experience in HPLC, GC and analytical laboratory operations

Knowledge of cGMP, GDP and regulatory requirements

Experience in API manufacturing quality control activities

Knowledge of laboratory investigations (OOS/OOT/Deviation)

Understanding of data integrity and documentation practices

Positive communication and teamwork skills

Preferred candidate profile

Location: Dahej SEZ, (Bharuch) Gujarat

Department: Quality Control (QC) in API Mfg. plant

Experience: 3 to 6 Years

Qualification: B. Pharm / M.Sc. (Chemistry)

📌 Officer To Sr Officer For Qc Analyst For Api Mfg Raks Pharma Dahej (India)
🏢 Amneal Pharmaceuticals
📍 India