Amneal Pharmaceuticals is hiring for four positions in Ahmedabad City, Gujarat, across Microbiology, Quality Assurance (QA), Analytical Quality Control (QC), and Regulatory Affairs. The openings include three Junior Executive positions and one Executive position in Regulatory Affairs.

Candidates with qualifications in Microbiology, Biotechnology, Pharmacy, Chemistry, Analytical Sciences, and related fields can review the eligibility criteria and responsibilities before applying.

Amneal Pharmaceuticals Recruitment 2026 – Job Details

Amneal Pharmaceuticals Job Openings

1. Junior Executive – Microbiology

Department: Quality Control Microbiology

Key Responsibilities:

• Perform environmental monitoring of classified clean rooms.
• Conduct microbial testing of products, raw materials, water, and other study samples.
• Ensure compliance with Good Laboratory Practices (GLP).
• Prepare microbiological media and perform growth promotion tests.
• Maintain documentation in accordance with cGMP standards.
• Coordinate equipment qualification, calibration, and preventive maintenance.
• Maintain laboratory documents, SOPs, study protocols, and equipment qualification protocols.
• Maintain audit readiness and participate in cross-functional training.

Eligibility and Qualifications:

• M.Sc. in Microbiology or Biotechnology.
• Good verbal and email communication skills.
• Basic knowledge of MS Word, Excel, and PowerPoint.
• English proficiency in reading, writing, and speaking.
• Willingness to work rotational shifts, weekends, and extended hours when required.

2. Junior Executive – Quality Assurance

Department: Quality Assurance

Role Summary: Manage the Document Management System (DMS), Training Management System (TMS), and routine quality assurance compliance activities.

Key Responsibilities:

• Review, issue, and archive controlled documents in the DMS.
• Maintain the document cell, ensuring proper storage, controlled access, and retrieval.
• Track SOPs, formats, logbooks, and revised document versions.
• Maintain employee training matrices and verify training records, including those of new joiners.
• Coordinate with cross-functional teams to resolve documentation and training gaps.
• Ensure compliance with GMP, GDP, and ALCOA+ requirements.

Eligibility and Qualifications:

• B.Pharm, M.Pharm, or M.Sc. in Biotechnology, Microbiology, or a related field.
• Strong understanding of GMP and data integrity.
• Good communication, coordination, and documentation skills.

3. Junior Executive – Quality Control

Department: Analytical Quality Control

Role: Raw Material and Packing Material Quality Control

Key Responsibilities:

• Manage sample receipt, entry, exit, and test sample requests.
• Perform raw material and packing material testing according to schedules and GMP requirements.
• Conduct raw material sampling, packing material sampling, and physical verification of consumables.
• Prepare raw material and packing material specifications and DRS.
• Analyse primary, secondary, and tertiary packing materials.
• Support method verification, equipment qualification, calibration, cleaning, and maintenance.
• Prepare analytical results, compile data packets, and submit results for review.
• Follow applicable USP, EP, JP, and IP test procedures.
• Maintain GMP documentation, data sheets, and LIMS records.
• Support audit preparation, SOP updates, and laboratory training records.

Eligibility and Qualifications:

• Master’s degree in Science, with qualifications in Chemistry, Analytical Sciences, or Biotechnology.
• Good verbal and email communication skills.
• Strong attention to detail and a compliance-focused approach.
• Basic knowledge of MS Word, Excel, and PowerPoint.
• Willingness to work in shifts as required.

4. Executive – Regulatory Affairs

Department: Regulatory Affairs

Key Responsibilities:

• Review ANDA submission activities and post-approval procedures in line with ICH and USFDA guidelines.
• Review API Drug Master Files (DMFs) and DMF change notifications for USFDA regulatory compliance.
• Review post-approval change cases against applicable ICH quality and USFDA guidance.
• Prepare Annual Reports and support CBE-0, CBE-30, and Prior Approval Supplement (PAS) submissions.
• Conduct preliminary reviews of regulatory submission packages.
• Draft controlled correspondence and briefing packages for the FDA when required.
• Support commercial marketing status notifications in accordance with FDA recommendations.
• Coordinate with cross-functional teams to obtain documents for regulatory submissions.
• Draft and review regulatory CTD modules.
• Maintain regulatory information and support timely submission preparation.

Eligibility and Qualifications:

• B.Pharm is required.
• M.Pharm is preferred.
• Required experience: 5–8 years.
• Knowledge of ANDA submissions, API DMFs, post-approval submissions, ICH guidelines, and USFDA requirements.

Required Skills:

• Analytical thinking and problem-solving.
• Cross-functional collaboration.
• Data governance and compliance.
• Documentation and record control.
• Effective communication.
• Regulatory intelligence and compliance.
• Regulatory filings and reporting.