About this role
Description:
To lead the Chemical Quality Control function at the injectable manufacturing site, ensuring timely, accurate, and compliant testing of raw materials, in-process samples, finished products, stability samples, and cleaning validation samples. The role ensures strict adherence to regulatory standards, drives data integrity, and maintains the readiness of the QC Chemical lab for inspections and audits.
Essential Functions:
- To Manage the QC Chemical laboratory operations including wet chemistry, instrumental analysis (HPLC, GC, UV, IR, etc.), and stability studies.
- Ensure efficient resource utilization and timely release of test results as per business requirements.
- Ensure all QC chemical activities are performed in compliance with cGMP, GLP, and data integrity standards.
- Review and approve test procedures, specifications, analytical methods, and associated documentation.
- Lead the investigation of OOS, OOT, deviations, and implement effective CAPAs.
- Ensure proper maintenance, qualification, and calibration of analytical instruments.
- Oversee the lifecycle management of equipment including procurement, validation, and decommissioning.
- Lead and mentor a team of QC Chemists and Analysts, ensuring continuous development and training.
- Conduct periodic performance reviews and skill-gap analysis to strengthen team capabilities
- Ensure the QC Chemical lab is always in a state of readiness for regulatory and customer audits.
- Represent the QC Chemical function during audits and ensure timely closure of observations related to chemical testing.
- Support technology transfers, method validations, cleaning validations, and new product introductions from the chemical testing perspective.
- Coordinate with QA, RA, Production, and other functions for seamless quality operations.
Additional Responsibilities:
Lead and oversee all Quality Control (QC) activities for API manufacturing.
Act as QC Lead, providing strategic direction and technical leadership to the QC team.
Ensure compliance with cGMP, regulatory guidelines, and data integrity requirements.
Review and approve analytical results, OOS/OOT investigations, and CAPAs.
Manage QC documentation, SOPs, validation, and change control activities.
Coordinate with QA, Production, Engineering, and Regulatory teams.
Support internal, customer, and regulatory audits/inspections as the QC Lead representative.
Drive continuous improvement, team capability building, and performance management.
Other facts
About Amneal
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 [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
What you'll do
- Lead the Chemical Quality Control function at the injectable manufacturing site, ensuring compliance with regulatory standards and timely testing of various samples. Manage laboratory operations, oversee QC activities, and mentor a team of QC Chemists and Analysts.
Ready to join Amneal?
Take the next step in your career journey