Job Description

To ensure compliance with cGLP regulations by analysis and calibration of all aspects of Quality Control at the manufacturing site

Essential Functions:

To be responsible for Analysis and Calibrations of Quality Control Laboratory instruments.
To be responsible for Receipt, verification, storage and issuance of laboratory chemicals and glassware.
To be responsible for Preparations of volumetric solutions, test solutions, limit test solutions and indicator solutions.
To be responsible for Maintaining of Good Laboratory Practices in lab.
To be responsible for Checking regular cleanliness of laboratory.
To be responsible for Management of all types of Standards.
To be responsible for Receiving and maintenance of Chromatographic columns.
To be responsible for Cleaning of Instruments.
To be responsible for Receiving samples and In-warding them in the respective registers/LIMS.
To be responsible for Preparation and execution of Protocols.
To be responsible for Maintain the contact with vendor.
To be responsible for Daily temperature monitoring of QC laboratory

Additional Responsibilities:

To be responsible for Investigation related to LIR, deviations, OOS and OOT.
To be responsible for Initiation of Deviations, OOS, OOAL, CRN and CAPA's.
To be responsible for Handling of Caliber e-LIMS
Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HOD's instruction and guidance.

Education:

Bachelors Degree (BA/BS) B. Pharm - Required
Master Degree (MS/MA) M. Sc. - Preferred
Master Degree (MS/MA) M. Pharm - Preferred

Experience:

2 years or more in 2 - 4 Years

Skills:

Analytical Instrumentation Handling - Advanced
Particulate Matter Testing - Proficient
Good Laboratory Practices (GLP) Compliance - Proficient
Data Integrity & Documentation - Proficient
Regulatory Compliance & Audit Preparation - Proficient
SOP Preparation & Revision - Proficient
Analytical testing expertise and evaluation skills - Proficient
Handling of Analytical Instruments and Interpretation of Resulting Data - Proficient
Laboratory Instrument qualification, Calibration & Maintenance - Proficient
Quality Control & Compliance - Proficient
LIMS Operation & Data Management - Proficient
QMS Documentation (OOS, OOT, Incident) - Beginner
CAPA, Deviation, and Change Control Management - Beginner

Specialized Knowledge: Licenses:

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.

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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

Website

amneal.com

Social Media

Senior Officer, Quality Control

Job Description

About Amneal Pharmaceuticals