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.