Executive, QC Environment Monitoring

Amneal Pharmaceuticals is seeking a detail-oriented and quality-focused Executive – QC Environment Monitoring to ensure effective environmental monitoring and compliance with cGMP standards across manufacturing operations. The involves monitoring cleanroom environments, reviewing critical quality documents, supporting validation activities, and ensuring adherence to regulatory and quality requirements. The candidate will play a key in maintaining aseptic conditions, supporting production processes, and ensuring the highest standards of quality in injectable pharmaceutical manufacturing.

Roles & Responsibilities

• Perform line clearance activities before operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing.
• Conduct environmental monitoring of cleanroom areas as per defined schedules and SOPs.
• Perform non-viable particle monitoring in manufacturing cleanroom environments.
• Carry out compressed air, nitrogen gas, and personnel monitoring activities.
• Participate in process validation, cleaning validation/verification, hold time studies, and media fill simulations.
• Perform routine batch sampling and monitoring as per approved protocols.
• Conduct in-process testing at various stages as per batch documents and SOPs.
• Review executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs).
• Review environmental monitoring trends and water system trends for compliance.
• Review calibration certificates and ensure instruments are within calibration status.
• Review critical printouts such as CIP, SIP, autoclave cycles, and filter integrity test reports.
• Coordinate with microbiology lab for issuance and return of EM monitoring materials such as plates, swabs, and samplers.
• Ensure proper documentation and completion of all applicable formats in aseptic areas.
• Maintain issuance and reconciliation records for environment monitoring materials.
• Monitor and ensure cGMP compliance on the shop floor.
• Participate in qualification activities of manufacturing areas and equipment.
• Review media fill records and contamination data for compliance.
• Review visual inspector qualification records and ensure adherence to standards.
• entify and report any deviations or non-conformities during monitoring activities.
• Support internal audits, regulatory inspections, and ensure audit readiness.
• Ensure adherence to SOPs, quality systems, and regulatory guidelines.
• Maintain proper documentation practices in line with GDP requirements.
• Coordinate with cross-functional teams to address quality and compliance issues.
• Contribute to continuous improvement initiatives in environmental monitoring and quality systems.

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.