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JOB DETAILS

Senior Executive, Quality Control

CompanyAmneal
LocationAhmedabad
Work ModeOn Site
PostedOctober 26, 2026
About The Company
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
About the Role

Department:  Quality control Analytical

Role:  QC (Compliance)
Role Summary: 

  • As a QC Analytical person, the role involves managing samples from receipt to release, ensuring timely analysis and accurate documentation in compliance with GMP/GLP standards. Responsibilities include performing analytical testing, compiling results, and supporting equipment qualification, calibration, and maintenance. The position also requires participation in stability studies, handling deviations and corrective actions, and maintaining training and regulatory records. Additionally, the role supports audit readiness, SOP development, and continuous improvement initiatives to uphold quality systems and regulatory compliance.

Roles & Responsibilities

Responsibilities:

 

  • Review of Cleaning records of area, Equipment daily verification/ calibration Data.

  • Review of All logbooks of QC Analytical department.

  • Review of all data i.e. In process, Drug Substance, Stability studies, Protocols, Raw material, packing material, method validation/verification/transfer data.

  • Identify and escalate deviations observed during review.

  • To provide issuance of Document numbers to QA.

  • To Compile and verify the Data packages of Batch records and submission to QA.

  • To prepare Stability Summary report, Trending of Lab incidents, invalids of QC Analytical department.

  • Compliance, Audit & Regulatory Support

  • Preparation and review of QC Analytical SOPs.

  • Review of equipment audit trail and alarms as well as perform data audit trails.

  • Ensuring adherence to cGMP, operational SOPs, and regulatory expectations.

  • To assist in writing SOP documents, change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design.

 

 

Basic Requirements:  

  • Qualification: Master’s degree in science

  • Good verbal and email communication skills

  • Attention to detail and strong compliance mindset

  • Curiosity to read, learn and working across cross-functional teams

  • Basic MS Office: Word, Excel, PowerPoint

  • Flexible to work in shifts as per operational requirements.

Qualifications

Life Science Graduate & Post Graduate

Key Skills
Quality ControlGMPGLPAnalytical TestingComplianceSOP DevelopmentAudit ReadinessData ReviewStability StudiesCalibrationEquipment QualificationDocumentationMS OfficeCommunication SkillsRegulatory Compliance
Categories
Science & ResearchManufacturingHealthcare
Job Information
📋Core Responsibilities
The role involves managing analytical samples from receipt to release while ensuring compliance with GMP/GLP standards. Responsibilities include reviewing cleaning records, logbooks, and analytical data, as well as supporting audit readiness and SOP development.
📋Job Type
full time
📊Experience Level
2-5
💼Company Size
7735
📊Visa Sponsorship
No
💼Language
English
🏢Working Hours
40 hours
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