Establishing Quality standards, Upgrading Quality Systems as per cGMP, GLP and ICH standards
Prepare, revise and implement Standard Operating Procedures.
Prepare “Site Master File” , Qualification & Validation (facility, equipment, analytical methods and process validation) and update it as and when necessary.
Training personnel on quality aspects across various departments in the organization
Conducting internal audits as part of self inspection program to ensure compliance of GMP standards and also conduct vendor audit.
Supervise manufacturing operations right from dispensing of raw materials / packing materials to completion of the batch.
Conducting Quality Reviews (APQR).
Change control, deviation investigation and handling of market complaints.
Preparing specification for RM, intermediates, in-process analysis and finished products and their test methods, making CTD (technical document) etc… as per sop’s and customer requirement.
Generate data (through testing by Q.C Lab) for all products regarding its stability.
