Manager - QA (FAN)
Posted Updated
Description
<p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">1. To implement quality policies and procedures and to ensure their</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">compliance in Food and Nutrition site/ Contract Manufacturing Site</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">2. To formulate Quality Management Systems to ensure cGMP / GLP / GDP</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">compliance at manufacturing, laboratory, warehouse and engineering to</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">meet current regulatory standards.</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">3. To Authorize/Approve the Standard Operating Procedures, Standard Test</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">Procedures, Specifications, Technical Documents (TDs), Protocols and</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">reports, APQRs etc.</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">4. To co-ordinate for audits by the external agencies, regulatory authorities and</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">formation of response to regulatory authorities and customers</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">5. To conduct internal quality audits to review the implementation of systems</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">as per the design to ensure cGMP compliance at site.</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">6. To ensure proper training & development of all QA personnel.</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">7. To release or reject or hold the batch of finished products for sale and</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">distribution.</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">8. To ensure the distribution, retrieval, archival, storage and retention of all</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">records related to plant.</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">9. To ensure the vendors approval and approval of contract manufacturing</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">sites as per company’s standard operating procedures including compliance</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">to quality system.</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">10. To ensure safety measures in the operation of plant.</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">11. To evaluate the performance of quality assurance department personnel.</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="text-indent:-0.25in;"><span style="font-family:Georgia;">12. Responsible for disposition and Authorization of Change Controls,</span></span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">Incidents, Deviations, OOS, OOTs non- conformance report (NCRs) Yield</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">nonconformance report (YNCRs), market complaints and Corrective actions</span></p><p class="MsoFooter" style="margin-top:0in;margin-right:-12pt;margin-bottom:0.0001pt;margin-left:45pt;text-indent:-0.25in;line-height:115%;"><span style="font-family:Georgia;">& Preventive Actions (CAPA).</span></p>