Senior Executive/Assistant Manager - US QA

<h2 style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Job Title:</span></strong><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;"> Sr. Executive / Assistant Manager – US QA</span></span></h2><p></p><h3 style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Experience:</span></strong><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;"> 7–12 Years</span></span></h3><p></p><h3 style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Qualification:</span></strong><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;"> M.Sc / M.Pharm</span></span></h3><p></p><p class="MsoNormal" style="margin-bottom:0.0001pt;"><span style="font-family:Roboto;"> </span></p><h2 style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Job Purpose</span></strong></h2><p></p><p style="margin:0cm;margin-bottom:0.0001pt;"><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">To provide </span><strong><span style="font-family:Roboto;">Quality Assurance support</span></strong><span style="font-family:Roboto;"> to </span><strong><span style="font-family:Roboto;">US-based manufacturing and quality operations</span></strong><span style="font-family:Roboto;">, ensuring compliance with </span><strong><span style="font-family:Roboto;">global cGMP, ICH, and regulatory requirements</span></strong><span style="font-family:Roboto;">, with a strong focus on </span><strong><span style="font-family:Roboto;">biosimilars</span></strong><span style="font-family:Roboto;">. The role supports batch release, quality systems, validation, and continuous improvement initiatives in collaboration with global cross-functional teams.</span></span></p><p></p><p class="MsoNormal" style="margin-bottom:0.0001pt;"><span style="font-family:Roboto;"> </span></p><h2 style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Key Responsibilities</span></strong></h2><p></p><h3 style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">US QA & Compliance</span></strong></h3><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Provide </span><strong><span style="font-family:Roboto;">QA oversight and support</span></strong><span style="font-family:Roboto;"> to US-based manufacturing and quality operations.</span></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Ensure compliance with </span><strong><span style="font-family:Roboto;">global cGMP, ICH, FDA</span></strong><span style="font-family:Roboto;">, and applicable regulatory guidelines across QA activities.</span></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Review and approve </span><strong><span style="font-family:Roboto;">Batch Manufacturing Records (BMRs)</span></strong><span style="font-family:Roboto;"> and </span><strong><span style="font-family:Roboto;">Certificates of Analysis (CoAs)</span></strong><span style="font-family:Roboto;">.</span></span></p><h3 style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Quality Systems & Investigations</span></strong></h3><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Support and review </span><strong><span style="font-family:Roboto;">deviation investigations, CAPAs, and change control</span></strong><span style="font-family:Roboto;"> activities; ensure timely closure in line with internal SOPs.</span></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Participate in </span><strong><span style="font-family:Roboto;">risk assessments</span></strong><span style="font-family:Roboto;">, </span><strong><span style="font-family:Roboto;">root cause analysis</span></strong><span style="font-family:Roboto;">, and </span><strong><span style="font-family:Roboto;">continuous improvement initiatives</span></strong><span style="font-family:Roboto;">.</span></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Contribute to the </span><strong><span style="font-family:Roboto;">global harmonization of quality systems and SOPs</span></strong><span style="font-family:Roboto;">.</span></span></p><h3 style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Validation, Tech Transfer & Documentation</span></strong></h3><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Provide QA guidance for </span><strong><span style="font-family:Roboto;">technology transfers</span></strong><span style="font-family:Roboto;">, </span><strong><span style="font-family:Roboto;">process validation</span></strong><span style="font-family:Roboto;">, </span><strong><span style="font-family:Roboto;">qualification</span></strong><span style="font-family:Roboto;">, and </span><strong><span style="font-family:Roboto;">process improvement initiatives</span></strong><span style="font-family:Roboto;">.</span></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Review and approve </span><strong><span style="font-family:Roboto;">SOPs, validation protocols, qualification documents</span></strong><span style="font-family:Roboto;">, and other technical documentation.</span></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Maintain </span><strong><span style="font-family:Roboto;">electronic and paper-based documentation</span></strong><span style="font-family:Roboto;"> in compliance with </span><strong><span style="font-family:Roboto;">ALCOA+ data integrity principles</span></strong><span style="font-family:Roboto;">.</span></span></p><h3 style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Quality Metrics & Reporting</span></strong></h3><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Monitor and track </span><strong><span style="font-family:Roboto;">key quality metrics</span></strong><span style="font-family:Roboto;"> and KPIs.</span></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Prepare and present </span><strong><span style="font-family:Roboto;">periodic quality reports</span></strong><span style="font-family:Roboto;"> for </span><strong><span style="font-family:Roboto;">US leadership and stakeholders</span></strong><span style="font-family:Roboto;">.</span></span></p><h3 style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Cross-Functional Collaboration</span></strong></h3><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Collaborate closely with </span><strong><span style="font-family:Roboto;">Manufacturing, Quality Control, Regulatory Affairs, and R&D</span></strong><span style="font-family:Roboto;"> teams to ensure consistent quality standards.</span></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Support regulatory inspections, audits, and responses as required for US operations.</span></span></p><p></p><p class="MsoNormal" style="margin-bottom:0.0001pt;"><span style="font-family:Roboto;"> </span></p><p style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Qualification:</span></strong></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><strong><span style="font-size:11pt;font-family:Roboto;">M.Sc / M.Pharm</span></strong><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;"> (Mandatory)</span></span></p><p></p><p style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Experience:</span></strong></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><strong><span style="font-size:11pt;font-family:Roboto;">7–12 years</span></strong><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;"> of QA experience in </span><strong><span style="font-family:Roboto;">biologics / biosimilars</span></strong></span></p><h3 style="margin:0cm;margin-bottom:0.0001pt;"><strong><span style="font-size:11pt;font-family:Roboto;">Technical Skills</span></strong></h3><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Strong knowledge of </span><strong><span style="font-family:Roboto;">cGMP, ICH, FDA regulations</span></strong><span style="font-family:Roboto;">, and global quality standards</span></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Hands-on experience in </span><strong><span style="font-family:Roboto;">BMR & CoA review and approval</span></strong></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Expertise in </span><strong><span style="font-family:Roboto;">deviations, CAPA, change control, and quality investigations</span></strong></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Experience in </span><strong><span style="font-family:Roboto;">biosimilars manufacturing, validation, and tech transfer</span></strong></span></p><p></p><p style="margin-top:0cm;margin-right:0cm;margin-bottom:0.0001pt;margin-left:36pt;text-indent:-18pt;"><span style="font-size:10pt;font-family:Symbol;"><span style="font-family:Roboto;">·</span><span style="font-size:7pt;line-height:normal;font-family:Roboto;"> </span></span><span style="font-size:11pt;font-family:'Calibri Light', sans-serif;"><span style="font-family:Roboto;">Sound understanding of </span><strong><span style="font-family:Roboto;">data integrity (ALCOA+)</span></strong><span style="font-family:Roboto;"> principles</span></span></p>