Amneal Pharmaceuticals

Senior Manager, Quality Control

Amneal Pharmaceuticals  •  Visakhapatnam, IN (Onsite)  •  4 hours ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description

The position is responsible for leading in-process and final product quality analyses and inspections in compliance with regulatory requirements and internal quality standards. The role focuses on interpreting and evaluating analytical results to ensure accuracy, precision, and adherence to established specifications. The role proactively identifies ongoing quality issues, prevents potential production and compliance risks, and recommends continuous improvement initiatives. The position ensures effective use of measuring devices, testing equipment, validated methods, and predefined procedures to accept or reject products. As a people leader, the role audits and monitors manufacturing processes, oversees random testing of finished goods, and ensures timely reporting and resolution of deviations and defects.


Essential Functions:

  • Lead in-process, finished product, and release testing activities
  • Interpret and evaluate analytical data against approved specifications
  • Identify recurring quality issues and prevent potential production risks
  • Ensure correct use of analytical instruments, methods, and procedures
  • Approve or reject materials and products based on QC outcomes
  • Audit and monitor manufacturing processes and quality outputs
  • Review and approve analytical data, COAs, and QC documentation
  • Lead deviation, OOS/OOT investigations and CAPA implementation
  • Ensure readiness for internal, external, and regulatory audits
  • Drive continuous improvement across QC systems and processes
  • Mentor, develop, and lead QC managers and laboratory teams



Additional Responsibilities:

  • Lead and oversee all Quality Control laboratory activities including Wet Laboratory, Instrumentation, Stability, and Microbiology (if applicable).
  • Ensure timely testing and release of Raw Materials, Intermediates, Finished Products, Stability Samples, and Cleaning Validation Samples.
  • Review and approve analytical data, certificates of analysis, specifications, methods, protocols, and reports.
  • Ensure compliance with cGMP, GLP, GDP, Data Integrity, and regulatory requirements.
  • Drive investigations related to OOS, OOT, Deviations, Laboratory Incidents, Market Complaints, and CAPA implementation.

Educational Qualification

  • M.Sc. (Chemistry/Analytical Chemistry/Organic Chemistry) / B.Pharm / M.Pharm
  • Strong understanding of cGMP, GLP, GDP, and Data Integrity requirements.

Education:

  • Master Degree (MS/MA) M. Sc. - Required
  • M. Pharm M. Pharm - Preferred

Experience:

  • 15 years or more in 15+ Years

Specialized Knowledge: Licenses:

Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

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.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
Social Media