[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-261165-105":53,"doc-detail-261165-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","ps-cr-product-quality-auditor-job-description-march-2021","PS CR Product Quality Auditor - Job Description - March 2021","","Product Quality Auditor role within Almac Pharma Services, supporting the Product Quality Team by reviewing batch records prior to QP certification and release. Responsibilities cover GMP-compliant review of manufacturing and packaging records for commercial and clinical operations, preparing batch disposition packs, appraising deviations or changes, and supporting OTIF-aligned delivery with required electronic transactions for KPI data. The position includes customer query handling, internal data verification, administrative duties, adherence to Quality Mission and Health & Safety, and participation in continuous improvement.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":16,"@type":70,"position":76},"https://docshare.wps.com/template/resumes/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/ps-cr-product-quality-auditor-job-description-march-2021/261165/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/ps-cr-product-quality-auditor-job-description-march-2021/261165.png","ImageObject",442,249,{"name":88,"@type":89},"Ivy","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-09-26","2026-09-14",true,{"@type":98,"interactionType":99,"userInteractionCount":79},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the overall objective of the PS CR Product Quality Auditor role?","Question",{"text":108,"@type":109},"The role supports the Product Quality Team by reviewing batch records prior to QP certification and release, ensuring GMP compliance and readiness for batch disposition.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Which activities support QP certification and release?",{"text":113,"@type":109},"The auditor reviews GMP-related manufacturing and packaging batch records and prepares the batch disposition pack, including assessing deviations or changes that impact GMP compliance.",{"name":115,"@type":106,"acceptedAnswer":116},"How does the role contribute to timelines and performance tracking?",{"text":117,"@type":109},"It supports batch delivery inline with OTIF timelines, performs associated electronic transactions to generate KPI data, and escalates anticipated issues to the Product Quality Team Leader while logging constraints as required.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},261165,1790349074,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":15,"category_name":16,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":79,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":47,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":139,"read_time":73},549758252649,"https://ap-avatar.wpscdn.com/avatar/8000253669c5317157?_k=1778319167496531819","JOB DESCRIPTION  \n\n| JOB DESCRIPTION CREATION DATE: | March 2021 |\n| --- | --- |\n| POSITION: |  PS CR Product Quality Auditor  |\n| BUSINESS UNIT: | Almac Pharma Services |\n| LOCATION: | Craigavon |\n| REPORTING TO: |  PS CR Product Quality Team Leader  |\n| RESPONSIBLE FOR (PEOPLE): | N/A |\n\nOVERALL ROLE OBJECTIVE:  \nThe post holder will work as part of the Product Quality Team responsible for review of batch records prior to QP certification and release.  \nJOB SPECIFIC RESPONSIBILITIES:  \n1. Review of Pharma manufacturing and packaging batch records pertaining to commercial and clinical operations for GMP compliance.  \n2. Preparation of the batch disposition pack to support QP certification , including the appraisal of any deviations or changes impacting GMP compliance.  \n3. Support Product Quality department objectives in relation to the delivery of batches inline with OTIF timelines , including performing the associated electronic transactions required to generate KPI data.  \n4. Ensure customer requirements for batch release are met in relation to Promise Date, escalate any anticipated issues in meeting these timelines to the Product Quality Team Leader and log constraints as required.  \n5. Respond to queries from internal and external customers in an accurate, timely and professional manner.  \n6. Perform data verification for internal data repositories.  \n7. Additional duties related to the assurance of GMP compliance and quality of manufactured and released pharmaceutical products, may also be assigned.  \n8. Contribute to and support continuous improvement initiatives within the Product Quality department.  \n9. Conduct administrative duties associated with the position as necessary.  \nThis role may require coverage beyond normal working hours as required. It is a condition of your employment that you are able to fulfil this requirement of the role.  \nQUALITY SPECIFIC RESPONSIBILITIES:  \nAlmac Pharma Services’ Quality Mission;  \nTo operate within a quality excellence framework that is both efficient and effective and continually assures safe and efficacious product to the patient.  \nThe post holder will, support the quality mission of the business by:  \n1. Ensuring exceptional and reliable quality in all aspects of work and recognising that quality determines the extent of success.  \n2. Engaging with the Pharmaceutical Quality System to ensure that quality records are completed accurately and proactively managed in line with committed timelines. Quality performance against set targets is a key goal and aligns with business objectives.  \n3. Actively contributing to the Quality Vision outlined by the Senior Management Team of reducing the gap between “where we are today” versus “where we want to be today”.  \nGENERAL ROLE RESPONSIBILITIES:  \n\n| Quality | Ensure GMP is adhered to in all areas of work. |\n| --- | --- |\n| Health & Safety | Understand Company’s Health & Safety Policy and follow all company HSE procedures. Report all accidents or any unsafe conditions in the work place. |\n| Training and Development | Ensure training has been received before undertaking specific duties and that all training is recorded in training records. |\n| Human Resource Management | Adhere to all HR policies and procedures, to include all absence policies and procedures. |\n| Communication | Communicate within your own department to ensure that all relevant information is forwarded to the appropriate personnel on a regular and timely basis. Provide regular updates to your line manager regarding progress on required duties and the status of any projects. |\n| Equal Opportunities | Observe and adhere to the company's Equal Opportunities and Dignity at Work policies ensuring that a neutral and harmonious work environment is maintained in which bullying and/or harassment does not occur. |\n| Core Competency Framework | Ensure that all job specific responsibilities relating to the overall role objective are carried out in accordance with the requirements","cbCaiaVEZn8MW0SI","https://ap.wps.com/l/cbCaiaVEZn8MW0SI","pdf",158463,"English","# Overall Role Objective\n## Job Specific Responsibilities\n## Quality Specific Responsibilities\n## General Role Responsibilities\n# Person Specification\n## Essential Requirement vs Desirable Requirement\n## ALMAC Core Competencies","[{\"question\":\"What is the overall objective of the PS CR Product Quality Auditor role?\",\"answer\":\"The role supports the Product Quality Team by reviewing batch records prior to QP certification and release, ensuring GMP compliance and readiness for batch disposition.\"},{\"question\":\"Which activities support QP certification and release?\",\"answer\":\"The auditor reviews GMP-related manufacturing and packaging batch records and prepares the batch disposition pack, including assessing deviations or changes that impact GMP compliance.\"},{\"question\":\"How does the role contribute to timelines and performance tracking?\",\"answer\":\"It supports batch delivery inline with OTIF timelines, performs associated electronic transactions to generate KPI data, and escalates anticipated issues to the Product Quality Team Leader while logging constraints as required.\"}]","PS CR Product Quality Auditor - Job Description - March 2021 | PDF",1789350010]