Manager

Competencies

MSc / M tech

12 to 20 years

To ensure cGMP compliance in laboratory.

To ensure timely initiation of procurement activity of consumables/ reagents.

To ensure the inhouse reference standard qualification and monitoring of trends.

To ensure timely calibration/ verification of equipment as per approved procedures of in-house as well as AMC schedules.

To ensure stability studies as per regulatory requirement, Protocol preparation, charging, analysis monitoring and stability study report compilation.

To ensure addressal regulatory queries, QC documentation related to QAMS.

Self-Improvement and knowledge update through training and referring to various literature, books, pharmacopeia and guidelines.

To ensure, fully documented method validations and method transfer activities

To ensure routine lab related compliance with respect to cleaning, availability of materials, validity of materials and facility up keeping.

To maintain laboratory in compliance with the regulatory requirements with their records and effectively implementation of SOP, cGMP and organization policies. 

To participate in LIR, deviation and OOS investigations.

To attend all GMP/ On-job/ additional trainings as per the approved training matrix and update the training records.