QA-QMS

Job Description

To perform investigation of Deviation,Market complaint, Adverse Drug Events, Alert notification and product failuresas per approved procedure. To ensure proper justification for thechange proposed with its impact analysis, risk assessment and effectivenesscheck with its acceptance criteria. To complete the preliminary investigationand final investigation report within stipulated time. To do document historical check withinference by examining relevant data sources with respect to the nature of theevent. To use appropriate investigation tool for investigation. To collectcircumstantial evidence and considering for investigation. To interviewpersonnel involved if needed in such a way that its relevant and adequate toidentify cause. To review batch records & relevant records and identify theindicators of an event. To identify the root cause based oninvestigation outcome. To perform vertical and horizontal impact assessmentbased on the root cause. To coordinate with cross functional teamfor immediate action which may be deemed necessary to isolate the event, tolimit any adverse effect on production, materials, equipment, areas, processes,procedures including discontinuation of processing or quarantine. To coordinate with contract givers foralert notification filing to the Agency, if applicable. To derive on appropriate CAPA inconsultation with CFT for the event with a justifiable target completion date. Todetermine appropriate CAPA effectiveness plan. To Handle the Change control andcheck the effectiveness of the proposed change. To prepare, execute and reviewof Process Validation and Cleaning Validation. To prepare and review SOPs in documentumsoftware against current regulatory guidance. To do trend analysis of QMS(Change control, deviations, CAPA, market complaints, FAR, and Product recall ). To participate in Regulatory audit/Customer audit and its compliance. To do trend analysis of repetitiveissues. To discuss outcomes of trend analysis with the QA head and suggestappropriate CAPA. To have a focus on the investigation to get the consistencyfor improving the quality of investigation. To evaluate the change for itsimpact and recommend actions based on the change, to identify any additionalmembers required for evaluation based on the change proposed. To maintain online entries in ZyQMS. Tomaintain APQR calendar/ schedule. To prepare and review the APQR. To monitorand prepare CPP report of product through validator and Minitab software. To prepare and review the visual inspection rejection trend in Minitab software. Qualification : M.Pharm Experience / Exposure : Must have knowledge and experience in injectableplant.