Senior Executive, Quality Control

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a Quality Control professional based in Ahmedabad, India. This role involves ensuring the quality of in-process and final products through rigorous testing and compliance with regulatory standards.

Candidates should possess a Bachelor's Degree in a relevant field along with 5 to 8 years of experience in quality control. The position demands strong analytical skills, effective communication, and a solid understanding of regulatory compliance and documentation practices.

Qualifications

• 5 to 8 years in quality control and analytical testing.

Responsibilities

• Perform In-Process Testing and Finished Product Testing as per approved methods.
• Execute Sampling and Testing Procedures for Raw Material, Packaging Material, In-Process, and Finished Goods.
• Interpret and evaluate analytical results for accuracy and precision.
• Review Analytical Data, Validation & Evaluation and maintain laboratory records.
• Conduct Laboratory Investigation & Change Control for deviations.
• Support Internal and External Audits and regulatory inspections.

Skills

Analytical Testing & Evaluation

Effective Communication

OOS Results Review & Analysis

Quality & Audit Preparedness

Regulatory Compliance

Technical Documentation

Validation & Qualification Oversight

Education

Bachelor's Degree (B.Sc.)

Master Degree (M.Sc.)

Job description

The position is responsible for in-process and final product quality analyses and inspection in compliance with established standards and regulatory requirements. The role involves interpreting and evaluating analytical results for accuracy and precision against approved specifications using defined methods, calibrated instruments, and prescribed procedures. The incumbent uses measuring devices and testing equipment to accept or reject products, tests random samples of finished goods, and audits, monitors, and determines the quality of manufacturing processes and outputs. The position identifies ongoing quality issues, prevents potential production risks, suggests improvements, and reports manufacturing process deviations and defects while maintaining robust GMP documentation and compliance.

Essential Functions

• Perform In-Process Testing (IPT) and Finished Product (FP) Testing as per approved methods
• Execute Sampling and Testing Procedures for RM/PM/IP/FG (Raw Material / Packaging Material / In-Process / Finished Goods)
• Interpret and evaluate analytical results for accuracy and precision
• Review Analytical Data Review, Validation & Evaluation and laboratory records
• Perform accept or reject decisions based on approved specifications
• Conduct Laboratory Investigation & Change Control for deviations and failures
• Review and approve Certificate of Analysis (COA) Documentation
• Support Internal and External Audits and regulatory inspections
• Identify quality trends and support Continuous Improvement initiatives
• Ensure strict adherence to Good Documentation Practices (GDP)
• Report manufacturing process deviations and finished goods defects
• Maintain compliance with 21 CFR Part 210 & 211

Additional Responsibilities

• Ensure destruction of solid and liquid samples which are unused or left over after analysis, and coordinate with other departments for sending samples for outside laboratory testing.
• Analyze and document Raw-materials and packaging materials.
• Investigate quality issues such as OOS, OOAL, incidents and deviations during laboratory activities.
• Prepare and standardize volumetric solutions/reagents and maintain related documents.
• Prepare, handle, and manage working/reference standards.
• Prepare SOPs and laboratory related documents.
• Ensure documentation is contemporaneous and legible.
• Perform analytical method transfer and verification for Raw material, and manage planning of samples to be analysed in quality control laboratory.
• Supervise quality control laboratory activity.
• Perform other activities/tasks assigned by HOD.

Qualifications

Education:

• Bachelors Degree (BA/BS) B. Sc. - Required
• Master Degree (MS/MA) M. Sc. - Preferred

Experience:

• 5 to 8 years in quality control and analytical testing.

Required Skills

• Analytical Testing & Evaluation
• Effective Communication
• OOS Results Review & Analysis
• Quality & Audit PreparednessQuality Control & Compliance Assurance
• Regulatory Compliance
• Technical Documentation
• Validation & Qualification Oversight

Job Info

• Job Identification 8106
• Job Category Quality Control
• Posting Date 05/30/2026, 07:38 AM
• Locations 882/1-871, Village Rajoda, Ahmedabad, GJ, 382220, IN