Executive, QA Validation

Amneal Pharmaceuticals is seeking a highly detail-oriented and quality-driven Executive – QA Validation to manage and execute validation and qualification activities while ensuring compliance with cGMP and regulatory standards. The involves preparation, review, and implementation of validation protocols and quality documents, coordination with cross-functional teams, and oversight of manufacturing and aseptic processes. The candidate will play a critical in maintaining quality systems, supporting regulatory requirements, and ensuring adherence to validation and compliance standards across operations.

Roles & Responsibilities

• Perform quality assurance functions related to validation and qualification activities.
• Prepare and review URS, DQ, and vendor/supplier qualification documents.
• Develop, review, and execute validation and qualification protocols and reports including process, equipment, and cleaning validation.
• Prepare and review media fill and hold time study protocols and reports.
• Coordinate with manufacturing, engineering, and QC teams for timely execution of validation and qualification activities.
• Ensure completion of re-qualification activities as per defined schedules.
• Review master and executed documents such as SOPs, BMRs, BPRs, QRM documents, investigations, and calibration records.
• Monitor and review trends related to environmental monitoring, WFI, and pure steam systems.
• Prepare, review, and implement SOPs within the Quality Assurance department.
• Ensure compliance with cGMP and regulatory requirements across all validation activities.
• Assess and manage change controls, deviations, CAPA, and investigation reports.
• Perform in-process quality checks at different stages as per batch documents and SOPs.
• Review in-process and finished product Certificates of Analysis (COA) before batch release.
• Monitor shop floor activities to ensure adherence to cGMP guidelines.
• Provide line clearance at different stages of manufacturing and packaging processes.
• Perform AQL (Acceptable Quality Level) checks for semi-finished and finished products.
• Conduct aseptic behavior and practice monitoring of operators during aseptic processing.
• Manage reserve sample collection, storage, periodic review, and destruction as per procedures.
• Track and manage stability samples as per approved protocols.
• Release finished products (FP), raw materials (RM), and packaging materials (PM) in LIMS.
• Provide required documentation and support to regulatory affairs for filings and audits.
• Identify training needs and conduct SOP and developmental training for team members.

Amneal Pharmaceuticals is a global pharmaceutical company focused on developing, manufacturing, and distributing a broad range of high-quality medicines. The company serves patients worldwide with a strong commitment to accessibility, innovation, and affordability.

Our Story

Amneal Pharmaceuticals was established with a vision to make essential medicines more accessible to patients across the globe. Over the years, the company has grown into a diversified pharmaceutical organization with a strong presence in multiple markets.

By combining scientific expertise with operational excellence, Amneal continues to expand its portfolio and global footprint.

Our Mission

• To provide high-quality and affordable medicines
• To improve patient access to essential healthcare solutions
• To drive innovation across pharmaceutical segments
• To maintain strong standards of quality and compliance

Our Vision

To be a leading global pharmaceutical company delivering accessible and innovative healthcare solutions.

Our Services / What We Offer

Amneal Pharmaceuticals offers a wide range of pharmaceutical solutions:

• Development and manufacturing of generic medicines
• Specialty pharmaceutical products
• Injectable and complex dosage formulations
• Global distribution of healthcare products

Why Choose Us

• Strong global presence across multiple markets
• Diverse portfolio of pharmaceutical products
• Focus on affordability and accessibility
• Advanced manufacturing and R&D capabilities
• Commitment to quality and compliance

Our Team

Amneal is supported by a global team of professionals, including scientists, researchers, and healthcare experts dedicated to delivering high-quality pharmaceutical solutions.

Infrastructure / Technology

The company operates advanced manufacturing facilities and research centers equipped with modern technologies to support innovation, efficiency, and quality assurance.

Our Commitment

Amneal Pharmaceuticals is committed to improving patient health by delivering safe, effective, and affordable medicines. The company focuses on innovation, operational excellence, and meeting global healthcare needs.