Assistant General Manager, Quality Assurance

Essential Functions

JOB DESCRIPTION

• Responsible for cGMP compliance review in QC laboratory
• Responsible tenure the completeness of the analytical documents and approval of CoA of Raw materials, packaging materials, In-process, finished products, stability study intended for submission, validation & commercial batches.
• Responsible to perform / review of the investigation for Quality issues like OOS, Deviations, Incidents, CSIR of QC laboratory
• Responsible to ensure the implementation of CAPAs recommended in OOS, OOAL, Incidents and deviations related laboratory.
• Responsible for the review of Change controls related to QC laboratory.
• Responsible for the review of chromatographic and non-chromatographic data in Empower / LIMS and its audit trail tenure the data integrity.
• Responsible for the review and approve of LIMS audit trail for Plant Locations tenure the data integrity.
• Participates in the development and implementation of SOPs for laboratory compliance or relevant QC functions.
• To ensure the adequacy of Standardization / Characterization data of working / Impurity standards in QC.
• To review and approve Quality control documents like qualification documents / Calibration report of instruments.
• Responsible to impart trainings the subordinates and other personnel for development.
• Responsible for review and approve of Raw material sample quantity evaluation form cum list and raw material storage condition for the materials applicable for Plant Locations.
• Responsible for review and approve of reduce and enhance reduce testing report of raw materials and packaging materials.
• Responsible for review of Elemental impurity and Nitrosamine impurity risk assessment report of the products applicable for plant locations.
• Responsible for management of manufacturer address of materials in BLPS software and approval of GRN in BLPS software.
• Responsible to review and approval of stability protocol in LIMS, Miscellaneous study protocols & related reports in laboratory.

Additional Responsibilities :

Education

QUALIFICATIONS

Experience

Skills

Specialized Knowledge : Licenses :

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

Skills Required

Investigation