{"id":3451,"date":"2021-03-31T13:47:30","date_gmt":"2021-03-31T13:47:30","guid":{"rendered":"http:\/\/geninvo.com\/poc\/?p=3451"},"modified":"2021-04-12T08:52:10","modified_gmt":"2021-04-12T08:52:10","slug":"analyst-lead-csv-qa","status":"publish","type":"post","link":"https:\/\/geninvo.com\/poc\/analyst-lead-csv-qa\/","title":{"rendered":"Analyst\/Lead \u2013 CSV\/QA"},"content":{"rendered":"\n<h5 class=\"wp-block-heading\"><strong>MAIN DUTIES\/RESPONSIBILITIES:<\/strong><\/h5>\n\n\n\n<ul class=\"wp-block-list\"><li>At a minimum, following activities are required to be performed;<\/li><li>Validation and Qualification activities for the infrastructure, systems and processes for GxP compliance throughout GENINVO.<\/li><li>Oversee the Organization\u2019s quality assurance organization to insure efficiency, quality, service, and cost-effective management of resources.<\/li><li>Work Closely with QA Manager on GxP audit programs for internal and external facilities as well as vendors and sub-contractors. This will include all study\/project audits, any deviations, CAPA and subsequent reporting programs that advise the study\/project director for potential impact.<\/li><li>Work Closely with QA Manager on managing client issues and expectations with regards to organizational quality systems.<\/li><li>Review of Project\/Study documents for accuracy and completeness.<\/li><li>Co-ordinate with the development staff to assure that the quality level and standard operating procedures within the organisation are implemented into the study\/project from inception till end.<\/li><li>Investigating customer complaints.<\/li><li>Perform other roles and responsibilities as assigned by the senior management<\/li><\/ul>\n\n\n\n<h5 class=\"wp-block-heading\"><strong>SKILLS &amp; EXPERIENCE<\/strong><\/h5>\n\n\n\n<ul class=\"wp-block-list\"><li>Bachelor\u2019s degree from a reputed university preferably in life science related fields<\/li><li>Must have excellent knowledge of cGxPs, Quality standards, industry best practices and regulatory affairs for life sciences and IT processes.<\/li><li>Expertise in regulatory affairs and requirements for clinical research processes.<\/li><li>Sound knowledge of aspects of SAS programming, project management, pharmacovigilance systems, clinical data management, data submissions, clinical trial monitoring.<\/li><li>Strong capability to execute audits, facilitate and drive investigations, root cause analysis, and corrective and preventive actions.<\/li><li>Good understanding of quality and project management methodologies.<\/li><li>Excellent knowledge of SDLC methodologies, software testing and validation &amp; verification<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>MAIN DUTIES\/RESPONSIBILITIES: At a minimum, following activities are required to be performed; Validation and Qualification activities for the infrastructure, systems and processes for GxP compliance throughout GENINVO. Oversee the Organization\u2019s quality assurance organization to insure efficiency, quality, service, and cost-effective management of resources. Work Closely with QA Manager on GxP audit programs for internal and [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[22],"tags":[],"class_list":["post-3451","post","type-post","status-publish","format-standard","hentry","category-job"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/geninvo.com\/poc\/wp-json\/wp\/v2\/posts\/3451"}],"collection":[{"href":"https:\/\/geninvo.com\/poc\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/geninvo.com\/poc\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/geninvo.com\/poc\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/geninvo.com\/poc\/wp-json\/wp\/v2\/comments?post=3451"}],"version-history":[{"count":0,"href":"https:\/\/geninvo.com\/poc\/wp-json\/wp\/v2\/posts\/3451\/revisions"}],"wp:attachment":[{"href":"https:\/\/geninvo.com\/poc\/wp-json\/wp\/v2\/media?parent=3451"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/geninvo.com\/poc\/wp-json\/wp\/v2\/categories?post=3451"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/geninvo.com\/poc\/wp-json\/wp\/v2\/tags?post=3451"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}