About this role
<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Description</H2> </div><div><p>Responsible for conducting corporate internal audits and review of various quality systems at site in adherence to CGMP, GxP, Data integrity and any other applicable regulatory requirements.<br>Review the Quality Regulatory Intelligence inputs and ensure its implementation across the network through review of gap assessments and compliance proposals; and verifying compliance actions for their implementation and effectiveness.<br>Review of regulatory commitments and its compliance<br>Perform gap assessment against regulatory audit observations, evaluate and co-ordinate with manufacturing sites for implementation of CAPAs.<br>Responsible for Quality metric data collection along with critical & repeated quality issues, status of quality initiatives/programs to be presented to senior management as part of Global Quality Corporate Steering Committee (GQCSC) meetings.<br>Impart training on SOPs to site personnel as and when required.<br>Support for any organizational corporate initiative assigned<br>Providing support for vendor audits as and when required<br>Coordinate with sites for evaluation of quality system and procedures as per requirement.<br>Providing inputs on Corporate Quality SOPs to comply with current regulatory guidance and requirements.<br>Shall review best procedures/practices followed at each site and inform to other manufacturing sites for implementation of harmonization procedures/practices across all locations.</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Work Experience</H2> </div><div><p>15-20 years of experience in Quality Management specifically Quality Assurance, Quality Control, Compliance, Auditing etc. Min. 5 years of experience in self inspections and / or auditing</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Education</H2> </div><div><div>Graduation in Pharmacy</div><div>Post Graduation in Pharmacy or Science</div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Competencies</H2> </div><div></div></div></div>