Description<\/p>\n
\tFine Chemicals requires the services of a Responsible Pharmacist & QA Manager. To qualify for these positions the most suitable candidates must fulfill the following requirements<\/p>\n
Requirements
\nJOB SPECIFICATIONS:<\/p>\n
\tMinimum requirement BPharm Degree
\n\tA minimum of 3-5 years of Manufacturing and Quality experience is needed
\n\tA minimum of 5-10 years of Management experience in Pharmaceutical, API, or medical device manufacturing facilities.
\n\tMust have 3-5 years of Management\/Supervisory experience
\n\tMust be registered with the Pharmacy Council
\n\tMust have completed Internship & Community Service
\n\tMust have experience in validation processes and requirements
\n\tMust have internal and overseas vendor auditing experience.
\n\tSound knowledge of GMP regulations (European, US, UK, WHO, PICS).
\n\tKnowledge of other pharmaceutical and scientific standards (ICH, Pharmacopoeia etc.)
\n\tKnowledge and understanding of Quality Management Systems in pharmaceutical and related industries.
\n\tMust have had exposure to international pharmaceutical practices.
\n\tKnowledge of engineering systems as relates to utilities and equipment in facilities.
\n\tSound knowledge of manufacturing products and processes.
\n\tKnowledge of packaging technology is an advantage.
\n\tMicrobiological experience would be advantageous
\n\tProduct registration experience would advantageous
\n\tComputer proficiency in MS Office and SAP.<\/p>\n
BASIC JOB FUNCTIONS (Brief Summary)<\/p>\n
\tSAHPRA Permit Applications
\n\tObtaining the necessary permits for import and export of Specified Schedule 5 and Schedule Substances.
\n\tHost customer and regulatory audits on behalf of Fine Chemicals.
\n\tTechnical, supply, and quality agreements are completed accurately and timeously.
\n\tEnsure annual renewal takes place with the South African Pharmacy Council (SAPC)
\n\tEnsure that Management Review (QSMR)of the Quality System is conducted periodically.
\n\tSuitable systems exist for the management of SOPs, change control, deviations are investigated and resolved, CAPA is raised where appropriate, and review and approval of all quality-related documents.
\n\tSystems are managed to ensure compliance with standards in QSMR meetings.
\n\tEstablish policies and procedures concerning acts performed and services provided in the company relating to scheduled substance.
\n\tEnsure that there is an effective system for the release\/rejection of all APIs\/intermediates for use outside the control of FCC.
\n\tTo ensure legal compliance to all Acts, i.e. the Pharmacy Act (Act No 53 of 1974, as amended) and the Medicines and Related Substance Control Act (Act 101 of 1965, as amended)
\n\tTo carry out the duties of a Responsible Pharmacist in accordance with Regulations 28 of the Pharmacy Act
\n\tTo act responsibly in the practice of pharmacist in accordance with operational requirements of the business
\n\tInitiate, compose, implement, and regularly update all documentation related to the Quality Unit.
\n\tTrain appropriate personnel in SOP\u2019s and other relevant areas.
\n\tAdminister and conduct internal audits.
\n\tParticipate in the batch release process by ensuring adherence of products to GMP guidelines.
\n\tManage and maintain the Quality Management System.
\n\tManage and control staff and other resources as required to meet the objectives of the Quality Unit and FCC.
\n\tAdhere to and promote compliance with H&S regulations.
\n\tConduct supplier audits and participate in vendor management processes.<\/p>\n
PERSONAL ATTRIBUTES (Brief Summary)<\/p>\n
\tGood organizational skills, proven leadership skills, and self-driven.
\n\tExceptional attention to detail and accuracy.
\n\tExcellent report writing and document reviewing skills.
\n\tUncompromising individual integrity and work ethic.
\n\tExercise interpersonal skills, communication, training, and problem-solving skills to optimize team performance.
\n\tDemonstrate initiative and apply advanced concepts
\n\tProven leadership skills, self-driven and motivated.<\/p>\n
Apply via company website ( ) or<\/p>\n
aspen.mcidirecthire.com<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/aspen.mcidirecthire.com","_company_name":"Aspen Pharma Group","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[15],"job-types":[12],"class_list":["post-14726","job_listing","type-job_listing","status-expired","hentry","job_listing_region-western-cape","job-type-full-time"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/14726","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=14726"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=14726"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=14726"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}