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:

Experience:

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:

Senior Officer, Quality Control

Amneal Pharmaceuticals