Senior Executive - QA - IPQA(DS)
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Description
<p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;"><b>Job Title</b>: Senior Executive QA (DSQA)</span></p><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;"><b>Department:</b> Quality Assurance</span></p><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;"><b>Experience:</b> 6 to 9 Years</span></p><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;"><b>Qualification:</b> M.Sc / M.Pharm</span></p><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><br /></p><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;"><b>Job Purpose -</b></span></p><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;">To ensure cGMP compliance at the shop floor for Drug Substance (DS) manufacturing through effective line clearance, documentation review, in-process oversight, and quality systems activities.</span></p><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;">Key Responsibilities</span></p><ul style="list-style-type:none;font-family:Manrope, sans-serif;padding-left:0px;color:rgb(9,30,66);"><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Perform manufacturing line clearance on the shop floor for DS activities.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Ensure proper execution and compliance of in-process checks during manufacturing operations.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Conduct routine GMP rounds at the Drug Substance facility and document observations.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Review online batch manufacturing records (BMR) for accuracy, completeness, and compliance.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Review and approve process validation protocols and reports, cleaning validation protocols and reports.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Review and manage Standard Operating Procedures (SOPs) and other protocols/reports related to shop floor operations.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Coordinate collection and submission of samples as per BMR, specifications, process validation, and stability protocols.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Perform regular shop floor compliance rounds to ensure adherence to cGMP and follow up on corrective actions.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Prepare and support Annual Product Quality Review (APQR/PQR) documents.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Initiate and manage Change Control, Deviations, Incidents, and CAPA, including investigation support and timely closure.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Participate in QMS investigations and root cause analysis.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Ensure continuous cGMP compliance and regulatory readiness at the shop floor.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Perform risk assessments for critical manufacturing and quality processes.</span></li></ul><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;"><b>Skills & Competencies -</b></span></p><ul style="list-style-type:none;font-family:Manrope, sans-serif;padding-left:0px;color:rgb(9,30,66);"><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Strong knowledge of cGMP, QMS, and regulatory requirements</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Hands-on experience with DS/DP shop floor QA activities</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Understanding of process validation, cleaning validation, and in-process controls</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Experience in BMR review and documentation control</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Good analytical, investigation, and problem-solving skills</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Effective communication and coordination with cross-functional teams</span></li></ul><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;"><b>Regulatory Exposure -</b></span></p><ul style="list-style-type:none;font-family:Manrope, sans-serif;padding-left:0px;color:rgb(9,30,66);"><li style="list-style-type:none;"><span style="font-family:DarwinSans;">USFDA, EMA, WHO, and other global regulatory guidelines (preferred)</span></li></ul>