Senior Executive - QA Validation
Posted Updated
Description
<p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;"><b>Key Responsibilities</b></span></p><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;">Validation & Qualification -</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;">Plan, execute, review, and approve equipment and instrument qualification activities including DQ, IQ, OQ, and PQ in compliance with regulatory guidelines.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Ensure effective execution of AHU qualification and HVAC validation activities.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Prepare, review, and maintain validation documentation as per approved Validation Master Plan (VMP).</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Support validation of critical utilities, systems, and processes related to biopharmaceutical manufacturing.</span></li></ul><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;">Quality Systems & Compliance -</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;">Ensure validation activities are aligned with the Quality Management System (QMS) and regulatory requirements.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Participate in deviation investigations, CAPAs, change controls, and risk assessments related to validation.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Maintain validation lifecycle approach and ensure data integrity and compliance.</span></li></ul><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;">Audit & Regulatory Support -</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;">Support and face regulatory inspections and customer audits including USFDA, EU, TGA, WHO, and other global agencies.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Prepare responses to audit observations related to validation and qualification.</span></li></ul><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;">Manufacturing & Operations Support -</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;">Provide QA validation oversight for aseptic filling operations and associated equipment.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Collaborate with Production, Engineering, QC, and Regulatory teams for validation activities, process improvements, and technology transfers.</span></li></ul><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;">Documentation & Continuous Improvement -</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;">Review SOPs, protocols, and reports related to validation activities.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Drive continuous improvement initiatives to enhance validation efficiency and compliance.</span></li></ul><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;"><b>Qualifications & Experience -</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;">M.Sc or M.Pharm (full time)</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">6-9 years of experience in QA Validation within the biopharmaceutical industry.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Strong experience with validation of equipment, instruments, AHUs, and aseptic filling operations.</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Hands-on experience with regulatory audits (USFDA, EU, TGA, etc.).</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">In-depth knowledge of biopharmaceutical products and cGMP requirements.</span></li></ul><p style="font-family:Manrope, sans-serif;margin-bottom:0px;color:rgb(9,30,66);"><span style="font-family:DarwinSans;"><b>Key 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 understanding of cGMP and regulatory guidelines</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Expertise in validation lifecycle management</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Excellent documentation and compliance skills</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Audit readiness and inspection handling</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Cross-functional collaboration</span></li><li style="list-style-type:none;"><span style="font-family:DarwinSans;">Analytical thinking and attention to detail</span></li></ul>