Executive, QA Validation

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a Quality Assurance specialist to lead qualification activities for equipment, utilities and systems. The role involves drafting and reviewing DQ/IQ/OQ/PQ protocols, coordinating with Engineering, Production, and Validation teams, and ensuring GMP compliance across documentation.

The candidate will perform risk assessments using FMEA, HACCP, and risk matrices, enforce data integrity under ALCOA+ principles, and drive continual improvement in quality

Qualifications

• Experience implementing GxP quality systems and regulatory requirements.
• Familiarity with qualification lifecycle (DQ/IQ/OQ/PQ) of equipment and systems.
• Experience performing risk assessments using FMEA, HACCP, or risk matrices.
• Understanding and application of ALCOA+ data integrity principles.

Responsibilities

• Prepare and review qualification protocols and reports for equipment, utilities, and systems.
• Coordinate qualification activities with Engineering, Production, and Validation teams.
• Ensure qualification documentation complies with GMP and regulatory requirements.

Skills

GAMP 5 & 21 CFR Part 11

ALCOA+

FMEA

HACCP

Risk matrices

IQ/OQ/PQ

Project management

Job description

Description

• Prepare and review qualification protocols and reports for equipment, utilities, and systems (DQ, IQ, OQ, PQ, as applicable).
• Coordinate and monitor qualification activities with Engineering, Production, and Validation teams.
• Ensure qualification documentation complies with GMP and regulatory requirements. Maintain qualification schedules and ensure periodic requalification is completed on time.
• Conduct quality risk assessments using tools such as FMEA, HACCP, or risk matrices.
• Identify potential quality risks and recommend appropriate mitigation strategies.
• Ensure risk management documentation is maintained and periodically reviewed.
• Draft, review, revise, and maintain Standard Operating Procedures (SOPs), work instructions, protocols, and quality documents.
• Ensure document control procedures are followed throughout the document lifecycle.
• Coordinate periodic review of controlled documents.
• Provide training on new or revised SOPs and maintain training records.
• Identify opportunities for process improvement and quality enhancement.
• Support implementation of quality metrics and trend analysis.
• Participate in cross-functional quality improvement projects.
• Develop and review process validation protocols, reports, and validation master plans.
• Coordinate execution of process validation activities with cross-functional teams.
• Evaluate validation data and ensure processes consistently meet predefined acceptance criteria.
• Support cleaning validation, analytical method validation, and computerized system validation where applicable.

Additional Skills

• Knowledge of GAMP 5 and 21 CFR Part 11.
• Strong Understanding of ALCOA+ principles.
• Performing risk assessments using tools like FMEA, HACCP, and risk matrices.
• Hands‑on experience with IQ, OQ, PQ, and requalification of manufacturing and laboratory equipment.
• Strong Project Management Skills