Typical accountabilities will include<\/p>\n
\tResponsible for overseeing the implementation and delivery of a common Quality system and strategy for GMP and GDP activities across in Commercial marketing company for all AZ product portfolio in South Africa (SA), Sub-Saharan Africa (SSA), French Speaking Africa (SSA) Marketing Company (MC).\u00a0
\n\tExecutes country strategy for Affiliate Quality and Marketing Company GMP\/GDP aligned with AZ\u2019s 2030 bold ambition strategy for market expansion, product launches and accessibility.\u00a0
\n\tAccountable for assurance of quality compliance with worldwide standards for all local GMP & GDP activities and connects the affiliate offices the broader Operations Quality and R&D organisation operating under One AZ QMS.\u00a0\u00a0
\n\tAccountable for compliance with all relevant Acts and Regulations.<\/p>\n
Job Description <\/p>\n
\tFor South Africa, develop, support and drive excellence in Affiliate GMP&GDP Quality activities to maintain the local License to Operate.\u202f\u00a0
\n\tPrimary point of GMP&GDP contact for the country and maintaining an effective governance structure to ensure oversight of quality activities.\u00a0
\n\tResponsible for QMS implementation in SA and SSA & FSA MC.
\n\tProvides leadership for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities in the SA\/SSA\/FSA MC.
\n\tResponsible for the coordination of Quality Management reviews across GxP functions for South Africa and SSA&FSA MC.
\n\tRepresents Quality on cross-functional and cross SET teams and steering committees related to Affiliate market.
\n\tDrive global standardisation, simplification and improvement of South Africa and SSA&FSA Quality Management processes.\u00a0
\n\tProvide training, supporting and coaching structure for Quality roles.
\n\tIs the primary point of expertise for GMP & GDP activities impacting the South Africa and SSA&FSA MC organizations.
\n\tResponsible for budget planning and adherence to budget for the Country, South Africa & SSA& FSA MC.
\n\tResponsible for promoting Quality Culture across AstraZeneca South Africa and SSA&FSA MC organizations.
\n\tAccountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common GxP process across the Affiliate GxPs within the MC.
\n\tAccountable for compliance to Country specific quality and regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to release of product batches, resolution of Issue Management, recalls, influence decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ licence to operate.
\n\tDemonstrated ability to work independently and in project settings to deliver objectives.
\n\tKeeps own knowledge of best practices, industry standards and new developments in quality management up to date.
\n\tEmploys prepared information to discuss, plan and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations.
\n\tEnsures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Distribution Practice and regulatory requirements of own work and others work.
\n\tResponsible for ensuring that policies and standards meet regulatory requirements.
\n\tCarries out compliance reviews and reporting for external suppliers including issue resolution with senior management and AZ site\/MC leaders, this may include, but is not limited to, the review and approval of investigation reports and participation in issue management teams.
\n\tSupports local SA, SSA & FSA MC to deliver the license to operate, including but not limited to support for GMP&GDP audits and inspections, implementation of effective self-assessment programs.
\n\tResponsible for the achievement of country KPIs and objectives\/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans.
\n\tContributes to development local procedures due to specific local regulatory requirements and provides some technical input into the development of global procedures and standards.
\n\tProactively looks for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring appropriate level of compliance<\/p>\n
ESSENTIAL SKILLS & EXPERIENCE REQUIRED<\/p>\n
\tCompleted Bachelor\u00a0of\u00a0Pharmacy\u00a0Degree\u00a0and\u00a0registration\u00a0with\u00a0the\u00a0South African\u00a0Pharmacy\u00a0Council
\n\tMinimum 5 years\u2019 experience as Responsible Pharmacist
\n\tAppropriate cross functional collation with key stakeholders at the MC-Regulatory\/Patient Safety\/Medical Information\/ Key Account Managers\/ Marketing\/ Supply\/ QA Pharmacist
\n\tAppropriate cross functional collation with Ops Distribution Country Leadership Team
\n\tStrong communication and influencing skills with accuracy and attention to detail
\n\tProject and people management
\n\tFluency in English is required.
\n\tMust be open to travel when necessary.<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( https:\/\/www.astrazeneca.com ) or<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"","_company_name":"AstraZeneca","_company_website":"https:\/\/www.astrazeneca.com","_company_tagline":"AstraZeneca is a global, science-led biopharmaceutical company that spans the discovery, development, manufacturing, distribution and worldwide commercialisation of primary care and speciality care medicines. We believe the best way we can help patients is to focus on breakthrough science in order t... read moreo uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines. We invest in distinctive science in three main therapy areas where we believe we can make the most meaningful difference to patients: oncology; cardiovascular and metabolic diseases; and respiratory, inflammation and autoimmunity. Our science exploits our rare combination of capabilities in small molecules and biologics, immunotherapies, protein engineering technologies and devices. These are reinforced by a strong focus on translational science and personalised healthcare capabilities. We build on our own capabilities by collaborating with world-renowned scientists and academic institutions and partnering with like-minded science-led companies. Through leading in science, we are confident that we can transform the lives of people around the world and deliver value to our shareholders. Building 2 Northdowns Office Park 17 Georgian Crescent West BRYANSTON - 2021 Johannesburg - South Africa","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[11],"job-types":[12],"class_list":{"0":"post-12838","1":"job_listing","2":"type-job_listing","3":"status-expired","4":"hentry","5":"job_listing_region-gauteng","7":"job-type-full-time"},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/12838","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/media?parent=12838"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=12838"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=12838"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}