{"id":8183,"date":"2024-08-23T08:39:24","date_gmt":"2024-08-23T03:09:24","guid":{"rendered":"https:\/\/pharmaceuticalcarrier.com\/?post_type=job_listing&#038;p=8183"},"modified":"2024-08-23T08:39:28","modified_gmt":"2024-08-23T03:09:28","slug":"walk-in-drive-in-quality-assurance-bio-bulk-manufacturing-at-enzene-biosciences-25th-aug-2024","status":"publish","type":"job_listing","link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/walk-in-drive-in-quality-assurance-bio-bulk-manufacturing-at-enzene-biosciences-25th-aug-2024\/","title":{"rendered":"Walk-in Drive in Quality Assurance, Bio-Bulk Manufacturing at Enzene Bioscience&#8217;s- 25th Aug 2024"},"content":{"rendered":"<div class=\"flex max-w-full flex-col flex-grow AIPRM__conversation__response\">\n<div class=\"min-h-[20px] text-message flex w-full flex-col items-end gap-2 break-words [.text-message+&amp;]:mt-5 overflow-x-auto whitespace-pre-wrap\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"862242bb-6837-4f6b-81db-353331d76c94\">\n<div class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[3px]\">\n<div class=\"markdown prose w-full break-words dark:prose-invert dark\">\n<p><strong>About Enzene Biosciences<\/strong><br \/>\nEnzene Biosciences is a technology-driven company based in Pune, India, committed to harnessing disruptive innovation to enhance global health. Our mission is to provide affordable, high-quality medicine to improve the lives of individuals with debilitating conditions. With a world-class R&amp;D infrastructure, we offer access to advanced technologies and an end-to-end development platform, ranging from proprietary CHO duos cell lines to comprehensive drug product development. Our cutting-edge analytical technologies accelerate the development of pre-clinical and clinical drug candidates.<\/p><div class=\"pharm-content\" id=\"pharm-2749453606\"><script async src=\"\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-8402705006112223\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display:block;\" data-ad-client=\"ca-pub-8402705006112223\" \ndata-ad-slot=\"7652789694\" \ndata-ad-format=\"auto\"><\/ins>\n<script> \n(adsbygoogle = window.adsbygoogle || []).push({}); \n<\/script>\n<\/div>\n<p><strong>Position: Quality Assurance (QA) Professionals<\/strong><br \/>\n<strong>Location: Hyderabad<\/strong><br \/>\n<strong>Experience Required: 4 to 12 Years<\/strong><br \/>\n<strong>Qualification: M.Sc\/M.Tech\/M.Pharm (Biotech, Bioprocess Technology, Life Sciences)<\/strong><\/p>\n<p><strong>Job Responsibilities:<\/strong><\/p>\n<p><strong>Vendor Management<\/strong><\/p>\n<ul>\n<li>Oversee vendor management, including the qualification and management of contract vendors and external service providers.<\/li>\n<li>Ensure compliance with quality management systems (QMS).<\/li>\n<\/ul>\n<p><strong>Validation QA<\/strong><\/p>\n<ul>\n<li>Review validation protocols and reports, such as URS, DQ, IQ, OQ, and PQ, particularly for cold chain products.<\/li>\n<li>Manage equipment validation and qualification for pharmaceutical sterile facilities.<\/li>\n<\/ul>\n<p><strong>Training &amp; Development<\/strong><\/p>\n<ul>\n<li>Design, implement, and oversee training programs to enhance employee skills and ensure compliance with industry standards.<\/li>\n<li>Collaborate with departments to identify training needs, develop materials, and evaluate program effectiveness.<\/li>\n<\/ul>\n<p><strong>Bio-Bulk Manufacturing (Drug Substance)<\/strong><\/p>\n<ul>\n<li><strong>Upstream Process<\/strong>: Expertise in media preparation, filtration, aseptic techniques, and handling of bioreactors.<\/li>\n<li><strong>Downstream Process<\/strong>: Proficiency in buffer preparation, filtration techniques, and chromatography.<\/li>\n<\/ul>\n<p><strong>Upstream Process Development (UPD)<\/strong><\/p>\n<ul>\n<li><strong>Mammalian<\/strong>: Handling AMBR250, expertise in perfusion technology, and process optimization.<\/li>\n<li><strong>Microbial<\/strong>: Experience with fermenters, process optimization, and characterization.<\/li>\n<\/ul>\n<p><strong>Advance Analytical Technique (AAT)<\/strong><\/p>\n<ul>\n<li>Proficient in analytical method development, qualification, and transfer.<\/li>\n<li>Experience with HPLC, UPLC, and other analytical instruments.<\/li>\n<\/ul>\n<p><strong>Method Validation Lab (Quality)<\/strong><\/p>\n<ul>\n<li>Perform method validation, stability sample analysis, and data review.<\/li>\n<li>Coordinate external calibration and in-house verification of instruments.<\/li>\n<\/ul>\n<p><strong>Downstream Process Development (DSP\/PPD)<\/strong><\/p>\n<ul>\n<li>Develop protein purification processes and troubleshoot manufacturing issues.<\/li>\n<li>Draft and review study protocols and reports.<\/li>\n<\/ul>\n<p><strong>Drug Product Development (DPD)<\/strong><\/p>\n<ul>\n<li>Experience in formulation development for therapeutic proteins.<\/li>\n<li>Knowledge of combination product development and regulatory requirements.<\/li>\n<\/ul>\n<p><strong>Quality Management System (QMS) &#8211; Quality Assurance (QA)<\/strong><\/p>\n<ul>\n<li>Conduct investigations, manage deviations, CAPA, and change control.<\/li>\n<li>Ensure compliance with regulatory guidelines like USFDA and EMA.<\/li>\n<\/ul>\n<p><strong>In Process Quality Assurance (IPQA)<\/strong><\/p>\n<ul>\n<li>Oversee batch manufacturing and perform online review of BMR.<\/li>\n<li>Coordinate with clients for report reviews and batch release.<\/li>\n<\/ul>\n<p><strong>Analytical Quality Assurance (AQA)<\/strong><\/p>\n<ul>\n<li>Manage stability protocols, data review, and chamber maintenance.<\/li>\n<li>Review analytical and microbial data for compliance.<\/li>\n<\/ul>\n<p><strong>Quality Control Analyst and Reviewer (QC Analytical)<\/strong><\/p>\n<ul>\n<li>Perform and review analytical tasks such as HPLC and ELISA.<\/li>\n<li>Prepare and review documents related to GMP, GLP, and regulatory standards.<\/li>\n<\/ul>\n<p><strong>Domestic Regulatory Affairs (Domestic-RA)<\/strong><\/p>\n<ul>\n<li>Provide regulatory input and documentation for biological products in India and ROW markets.<\/li>\n<li>Review documents and maintain regulatory product processes.<\/li>\n<\/ul>\n<p><strong>Global Regulatory Affairs (Global-RA)<\/strong><\/p>\n<ul>\n<li>Draft and review eCTD sections for regulated markets like the USA, Europe, and Canada.<\/li>\n<li>Devise strategies for eCTD filing and manage developmental requirements.<\/li>\n<\/ul>\n<p><strong>Walk-in Interview Details:<\/strong><br \/>\n<strong>Date:<\/strong> Sunday, 25th August 2024<br \/>\n<strong>Time:<\/strong> 9:30 AM &#8211; 6:00 PM<br \/>\n<strong>Venue:<\/strong> Hotel Green Park, Greenland, Begumpet, Hyderabad &#8211; 16<\/p>\n<p>Join us in our mission to innovate and improve global health. We look forward to meeting talented professionals eager to make a difference in the pharmaceutical industry!<\/p>\n<ul>\n<li>For more articles,\u00a0<strong><a href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/ayurveda\/\">Kindly Click<\/a>\u00a0here<\/strong>.<\/li>\n<li>For pharmaceutical jobs, follow us on<strong>\u00a0<a href=\"https:\/\/www.linkedin.com\/company\/pharmaceuticalcarrier\/?viewAsMember=true\" target=\"_blank\" rel=\"noopener\">LinkedIn<\/a><\/strong>\n<div class=\"job_description\">\n<p><strong>For more jobs, kindly visit our job section.<\/strong><\/p>\n<p><a href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/jobs\/\">www.pharmaceuticalcarrier.com\/Jobs<\/a><\/p>\n<\/div>\n<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"author":1,"featured_media":8185,"template":"","meta":{"_uag_custom_page_level_css":"","_promoted":"","_job_location":"Hyderabad","_application":"https:\/\/docs.google.com\/forms\/d\/e\/1FAIpQLSfkTFw2relwfvxq7qrmbgfI1KXBySewJK30Y8Zzhi3X0LlnsA\/viewform?pli=1","_company_name":"Enzene Biosciences","_company_website":"https:\/\/www.enzene.com\/","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-categories":[614],"job-types":[17],"class_list":{"0":"post-8183","1":"job_listing","2":"type-job_listing","3":"status-publish","4":"has-post-thumbnail","5":"hentry","7":"job-type-full-time"},"uagb_featured_image_src":{"full":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/08\/Enzene-Biosciences.jpg",1600,900,false],"thumbnail":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/08\/Enzene-Biosciences-150x150.jpg",150,150,true],"medium":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/08\/Enzene-Biosciences-300x169.jpg",300,169,true],"medium_large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/08\/Enzene-Biosciences-768x432.jpg",640,360,true],"large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/08\/Enzene-Biosciences-1024x576.jpg",640,360,true],"1536x1536":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/08\/Enzene-Biosciences-1536x864.jpg",1536,864,true],"2048x2048":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/08\/Enzene-Biosciences.jpg",1600,900,false],"authorship-box-avatar":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/08\/Enzene-Biosciences-150x150.jpg",150,150,true],"authorship-box-related":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/08\/Enzene-Biosciences-70x70.jpg",70,70,true],"sow-carousel-default":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/08\/Enzene-Biosciences.jpg",272,153,false]},"uagb_author_info":{"display_name":"Pharmacareer","author_link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/author\/grandirpharmagmail-com\/"},"uagb_comment_info":0,"uagb_excerpt":"About Enzene Biosciences Enzene Biosciences is a technology-driven company based in Pune, India, committed to harnessing disruptive innovation to enhance global health. Our mission is to provide affordable, high-quality medicine to improve the lives of individuals with debilitating conditions. With Read More","_links":{"self":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-listings\/8183","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media\/8185"}],"wp:attachment":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media?parent=8183"}],"wp:term":[{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-categories?post=8183"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-types?post=8183"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}