Executive

Job DescriptionTo 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.