KEY RESPONSIBILITIES<\/p>\n
Operational efficiency<\/p>\n
\tContribute to the creation and implementation of best practice processes and procedures to aid and improve operational performance and timeous release of product to market.
\n\tContribute to timeous implementation of QA projects.<\/p>\n
Operational activities:<\/p>\n
\tConduct, manage and coordinate batch release reviews and approve final product release to the market as per the legal requirements and guidelines set by SAHPRA and the Department of Health, and in line with the registered dossier.
\n\tAlways maintain and coordinate all the GMP principles as required by the SAHPRA as stipulated in the latest version of the SAHPRA \/ PIC\/S (Pharmaceutical Inspection Co-operation Scheme) guidelines for cGMP and related systems and procedures to ensure compliance.
\n\tLiaise and coordinate with relevant 3rd parties to ensure all pre-requisites are available to action a product release.
\n\tSAP releasing and processing, including but not limited to batch creation and amendments.
\n\tEnsure direct communication and continuous pursual of achieving annual plans and schedules (including but not limited to annual stability plan, annual product quality review schedule, Quality Agreement renewals, annual audit plan, departmental training plans).
\n\tLiaise and communicate any anomalies, non \u2013 compliances and discrepancies to the rest of the team and assist with deviations and investigations.
\n\tEnsure accurate capture of data across all electronic platforms.
\n\tAssist with any product related GMP activities, including but not limited to stability, annual product quality reviews, quality agreements, audits and risk assessments.
\n\tReview of executed Batch Manufacturing documents received from 3rd parties.
\n\tAssist in product recalls\/mock recalls.
\n\tEnsure Head office sample storage is accurately controlled and ensure S6 and SS5 registers remain balanced at all times.
\n\tMaintain in-house documentation relating to QA processes, ensuring compliance with current SAHPRA licensing conditions for import and export functions (procedures, forms, registers, records and reports).
\n\tReview and monitor the below but not limited to:
\n\tProduct change control process
\n\tIssue log (Including deviations, CAPAs, change control process, Investigations)
\n\tDestructions<\/p>\n
Risk Assessments<\/p>\n
\tInternal QMS documents: SOPs, forms, registers and records
\n\tTemperature monitoring during transportation<\/p>\n
General<\/p>\n
\tPerform any other duties as per changes in operational requirements of the department.
\n\tPerform any other duties as required.<\/p>\n
Requirements<\/p>\n
PRE-REQUISITES<\/p>\n
\tB. Pharm registered with the SA Pharmacy Council.
\n\tMinimum of 2 years Quality Control or Quality Assurance hands-on experience within the pharmaceutical industry.
\n\tKnowledge of the quality environment within the pharmaceutical industry.
\n\tWorking knowledge of cGMP and the maintenance of Quality Management Systems.
\n\tWorking knowledge of the requirements and process of batch release to the market.<\/p>\n
Apply via company website ( N \/ A ) or<\/p>\n
pharmadynamics.mcidirecthire.com<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/pharmadynamics.mcidirecthire.com","_company_name":"Pharma Dynamics (Pty) Ltd","_company_website":"http:\/\/N%20\/%20A","_company_tagline":"Pharma Dynamics is the country\u2019s leader in cardiovascular medication since 2012 - both in terms of value and volume \u2013 and is the fastest growing generic pharmaceutical company in South Africa. The organisation celebrates 19 years of improving the quality of life for South Africans after entre... read morenching its mark in the industry with the launch of Amloc and Bilocor \u2013 SA\u2019s two top selling anti-hypertensives. Today, Pharma Dynamics is active in more than 30 therapeutic areas, which include Heart Health, Diabetes, Central Nervous System (CNS), Female Healthcare, Antimicrobial, Pain, and Digestive Disorders categories. Pharma Dynamics also supplies a range of over-the-counter (OTC) products, including leading South African brands for cold and flu, allergies, heartburn and immune boosters, which are recommended and prescribed by leading doctors and pharmacists nationwide. The acquisition of Pharma Dynamics by Lupin Laboratories \u2013 the 7th largest global generics company \u2013 enables the organisation to harness the potential of global sourcing as a way to further reduce the cost of medicine. As a result, Pharma Dynamics will expand its operations in the areas of anti-infective, biosimilars, complex molecules and specialty products. Over and above the supply of medication, we at Pharma Dynamics believe in going beyond the pill and we are inspired by our potential to improve the quality of life for South Africans. That is why we have invested and implemented sustainable patient support and education programmes that assist healthcare providers in improving patient outcomes in diseases areas such as hypertension, diabetes, and depression, amongst others. These programmes are aimed at patient and individual empowerment to improve healthcare provision through prevention and lifestyle management.","_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":["post-17854","job_listing","type-job_listing","status-expired","hentry","job_listing_region-gauteng","job-type-full-time"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/17854","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=17854"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=17854"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=17854"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}