Amneal Pharmaceuticals – Job Openings for AGM – Quality Assurance

Join Amneal Pharmaceuticals, Inc. (NYSE: AMRX), a global leader in pharmaceutical manufacturing, at our USFDA-approved injectable facility in Pipan, Ahmedabad. We’re seeking an AGM – Quality Assurance to lead our quality compliance efforts and drive excellence in sterile manufacturing.

With a team of over 7,500 colleagues, Amneal is committed to delivering 270+ high-quality medicines worldwide. See the finance card above for AMRX stock details.

About Amneal Pharmaceuticals

Amneal Pharmaceuticals is a trusted name in the global pharmaceutical industry, specializing in sterile injectables, generics, and specialty pharmaceuticals. Our state-of-the-art facility in Pipan, Ahmedabad, adheres to stringent USFDA regulations, ensuring top-tier quality standards in every product.

With a diverse portfolio and a focus on innovation, Amneal is dedicated to improving global healthcare through cutting-edge manufacturing processes and robust quality systems. Our commitment to patient safety and regulatory compliance has positioned us as a preferred partner for healthcare providers worldwide.

Job Opportunity: AGM – Quality Assurance (Injectables)

We’re hiring a seasoned Quality Assurance leader to oversee quality systems and regulatory compliance at our injectable manufacturing facility. This role is pivotal in ensuring product integrity, audit readiness, and operational excellence in a USFDA-regulated environment.

The ideal candidate will bring extensive experience in sterile manufacturing and a proven track record in quality management.

Key Responsibilities

• Lead QA Team: Mentor and develop the quality assurance team, fostering a culture of continuous improvement and accountability.
• Regulatory Compliance: Ensure adherence to USFDA, MHRA, and other global regulatory requirements in all manufacturing and quality functions.
• Audit Readiness: Maintain inspection-ready status for regulatory and internal audits, addressing findings with effective Corrective and Preventive Actions (CAPA).
• Batch Release: Oversee timely release of manufactured batches, ensuring compliance with cGMP standards and quality specifications.
• Complaint Resolution: Handle market complaints through thorough root cause analysis, impact assessments, and implementation of corrective actions.
• Validation Oversight: Manage qualification/validation activities for equipment, systems, and facilities, ensuring seamless execution and compliance.
• Documentation: Review and approve SOPs, batch records, and validation protocols to maintain data integrity and regulatory compliance.

Qualifications and Experience

• Designation: AGM – Quality Assurance
• Qualification: B.Pharmacy/M.Pharmacy
• Experience: 15-18 Years in Quality Assurance within sterile/injectable, USFDA-approved manufacturing facilities

Skills:

• Expertise in Quality Management Systems (QMS), CAPA, and regulatory audits.
• In-depth knowledge of cGMP, 21 CFR, and ICH guidelines.
• Proficiency in batch release, complaint handling, and validation processes.
• Strong leadership and team management skills to drive quality initiatives.
• Excellent communication and problem-solving abilities for cross-functional collaboration.

Application Details

• Location: Pipan, Ahmedabad, Gujarat
• How to Apply: Send your CV with the subject line “Application for AGM-QA” to Ajaykumar.pandey@amneal.com
• Website: www.amneal.com

Disclaimer: Amneal does not use free email services (e.g., Gmail, Yahoo) for job offers or charge fees. Verify offers directly with Amneal and report suspicious activity to maintain candidate safety.

Why Join Amneal?

• Global Impact: Contribute to the production of 270+ high-quality medicines that improve global healthcare outcomes.
• Advanced Facility: Work in a USFDA-regulated injectable facility equipped with cutting-edge manufacturing technologies.
• Career Growth: Lead quality initiatives in Ahmedabad’s thriving pharma hub, gaining exposure to international regulatory standards.
• Collaborative Environment: Join a dynamic team dedicated to innovation, patient safety, and operational excellence.
• Professional Development: Access opportunities to enhance your expertise in sterile manufacturing and quality assurance.

Why This Role Matters

As an AGM – Quality Assurance, you’ll play a critical role in upholding Amneal’s commitment to quality excellence. You’ll lead efforts to ensure that every sterile injectable product meets the highest safety and efficacy standards, directly impacting patient lives worldwide.

This role offers the chance to collaborate with cross-functional teams, including production, R&D, and regulatory affairs, to streamline processes and maintain compliance. By driving audit readiness and continuous improvement, you’ll contribute to Amneal’s reputation as a trusted pharmaceutical leader.

Important Notes

• Candidates must have 15-18 years of QA experience in sterile/injectable, USFDA-approved facilities.
• Expertise in QMS, CAPA, batch release, and regulatory audits is mandatory.
• Only candidates with relevant pharma experience in injectable manufacturing will be considered.
• Shortlisted candidates will be contacted for further steps, ensuring a transparent hiring process.
• Candidates previously interviewed within the last 6 months should not apply.

How to Prepare for the Application

To stand out, ensure your CV highlights your QA leadership experience, USFDA audit exposure, and specific achievements in sterile manufacturing. Include details of validation projects, complaint resolutions, or audit successes to demonstrate your expertise.

Prepare to discuss your approach to cGMP compliance and team management during the interview. Candidates with a strong understanding of 21 CFR and ICH guidelines will have an advantage.

Apply now to lead quality assurance at Amneal Pharmaceuticals and make a lasting impact in the pharmaceutical industry. Visit www.amneal.com for more details about our mission and global reach.