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
🏢 Amneal Pharmaceuticals
📍 Dahej