Executive

Job Description • To update log and maintain documentation related complaint investigation at Goa site confirming to cGMP requirement and to carry out the investigation. • Receipt, Logging and maintaining of complaint sample. • Follow-up for additional information on complaints and complaint samples. • Responsible for timely closure of complaint investigations and to submit the response. • To carry out assessment for Regulatory notification. 6. Inspection of Reserve samples as a part of market complaint investigation. • Review of APQR/ stability/change control/Incident/deviation/OOS/OOT, investigation report and related documents as part of complaint investigation. • Responsible to co-ordinate with cross functional departments related to complaint investigation. • Trending and evaluation of market complaints. • To ensure the implementation of CAPA with respect to market complaints in timely and comprehensive manner. • Implementation of Procedures and reviewing the ongoing compliance related to market complaints. • To ensure the updation of harmonised / standardized procedure related to complaints and its implementation. • Represent in the regulatory and customer Inspections related to Investigation. To ensure the compliance for the external regulatory and customers audit w.r.t complaints and CAPA. • To carry out any additional work as and when assigned by Supervisor. • IT Applications: Usage of QMS related T. Codes in SAP, MS Office, Acrobat Reader, Departmental Drive, Home Drive, Skype, Outlook, GENESIS, HR Portal , Trackwise and Internet. • Maintain Environment, Health and Safety system as per ISO 14001:2015 & ISO 45001:2018. • Perform review of “Format Control Audit Log” monthly reports on a monthly basis for I&C department.