Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Sun Pharmaceutical Industries Ltd
Designation : Manager
Function : Production
Functional Area : Validation - Quality Engineering
Job Role Summary : Equipment and facility Validation, Qualification
Job Profile :
  • Build a cohesive Team to support Validation activity in A- 41 Mohali Location
  • Collaborate for creating a robust CAPA program
  • Equipment and facility Validation of A- 41 Mohali Location, along with site Specific teams, which includes preparation, review and execution of protocols, and Master Validation documents.
  • Preparation, Review and execute protocols & reports in facility involving utilities, engineering, manufacturing operation & cleaning which shall include but not limited to HVAC, water, compressed air, process/packing equipment w.r.t. qualification & validation
  • To ensure that all qualification and validation protocols include critical steps / components which are to be checked and validated
  • To prepare, review & ensure compliance & written procedure w.r.t. validation function
  • To co-ordinate, review and manage the training needs and records as a department training coordinator (DTC).
  • To prepare validation planner for all utilities and equipments
  • To ensure the implementation of current good manufacturing practices
  • To look after the maintenance & improvement of product quality as per specification
  • To provide the training to personnel involved in validation activities as & when required
  • Participate in Quality Improvement projects
  • To ensure that all systems and equipments are validated as per the procedure/ requirements and calendar
  • Responsible for Quality Management System compliance i.e., Handling of Deviation, Investigation, CAPA and CCR
  • Responsible to perform the internal and external audit as per the site specific procedure. Any other responsibility that may be assigned from time to time
Job Requirements :

Experience : 12 to 15 Yrs (in Validation / Qualification) in Pharma 

Work / Job Experience : 12-15 Years
Type of Experience : Production, Engineering, QA in Equipment Facility Validation, Qualification activities
Academic Qualifications :

 B.Pharm / M.Pharm

Website Linkedin Sun Pharmaceutical Industries Ltd

To apply for this job please visit careers.sunpharma.com.