QA Team Leader: 

Responsibility: 

? To establish validation master plan. 

? To coordinate for batch release/dispatch. 

? To plan and co-ordinate shift schedule for shop floor QAs (IPQAs). 

? To maintain the Logs pertaining to Qualification, Validation & study activities. 

? To review the Qualification, Validation and study protocol and reports as per respective SOP and maintain its documentation. 

? To review computerized system validations and maintain its documentation. 

? To plan and co-ordinate for QA oversight activities 

? Maintain up-to-date knowled.ge of qualification & validation standards and regulatory compliance requirements and act as SME. 

? Monitor qualification/ Validation activities in the organization and ensure site alignment pertaining to validation with organization standards and GMP guidelines. 

? Preparation and review of SOPs/ Policies. 

? To review calibration certificates 

? To impart training on GMP and related other technical topics. 

? To perform self-inspection in the facility. 

? To ensure implementation of CAPAs in timely manner. 

? To support /participate in Investigation of deviations, market complaint, product recall and other Quality relevant incidents, quality risk management. 

Qualification: Master in Chemistry, Biotechnology or Pharmacy