KEY RESPONSIBILITIES<\/p>\n
RA: Product registration<\/p>\n
\tConduct timeous compilation of due diligence on new dossier and communicates findings to Lupin or Third-Party Supplier as required
\n\t\u00a0Compile and submit any TB and\/or ARV dossiers to regulatory authorities in eCTD at agreed timelines
\n\tLiaise with regulatory authorities on New Dossiers, SAHPRA queries and variations when required
\n\tEnsure that Site Master Files are submitted to regulatory authorities for Overseas Third Party Supplier)
\n\tConduct due diligence on variations received from Third Party Suppliers or internal requirements
\n\tEnsure any variations are logged on the CCP register and managed until completion
\n\tCompile and submit all responses to regulatory authorities queries, Safety Updates and variations, within agreed and specified time limits.
\n\tManage the GMP compliance of API\u2019s and manufacturers on an ongoing basis and ensure any deviations or potential quality risks are communicated to the Responsible Pharmacist
\n\tMaintain the department\u2019s online apps (CCP database, docuBridge, Artwork app) as per official SOPs and\/or working instructions.
\n\tEnsure all dossier related procedures, templates and quality standards are adhered to
\n\tEnsure all correspondence and or dossier information is filed appropriately
\n\tMaintain an accurate product history and ensure the electronic database for regulatory dossiers are current and accurate
\n\tReview product artwork and ensures compliance with registration and labelling regulations of Medicines and Related Substances Act 101 of 1965, in line with tender requirement.
\n\tInteract with Lupin and Third-Party Suppliers on dossier related activities (supplier meetings)
\n\tProvide regulatory advice to internal and external stakeholders when required.<\/p>\n
QA: Product realization & Lifecycle activities:<\/p>\n
\tEnsure that timelines related to launch processes and product lifecycle maintenance are adhered to and that formal processes exist to govern product realization.
\n\tOversee and execute quality assurance operations for the preparation and release of products.
\n\tOversee and coordinate Lot Release preparations for products, ensuring compliance with GMP, the registered dossier and prescribed procedures.
\n\tEnsure that laboratory consumables are effectively procured and managed thereby ensuring timelines are met for any testing activities.
\n\tCompilation, conducting periodic updates and completion of Technical Quality Agreements related to product realization, if required.
\n\tCo-ordinating and conducting the Product Quality Reviews to assess the ongoing effectiveness of quality systems of newly launched products.
\n\tManage Analytical Method Transfer and Stability processes to ensure accurate and reliable testing.
\n\tConduct risk assessments and develop mitigation strategies where required.
\n\tCoordinate activities involved with product realization and product reworks, if required.
\n\tEnsure technical transfers or validation activities are performed as per the functions stipulated for the project team. Ensure timelines are strictly adhered to.
\n\tAssist with the compilation and\/or review of departmental QMS documentation.
\n\tEnsure destructions are recorded and managed effectively when required.
\n\tEnsure that good documentation practices are always adhered to and that data integrity is maintained.
\n\tConduct supplier audits to ensure compliance and quality of incoming products.
\n\tInitiate Issue Logs and drive investigations to track and address quality-related concerns promptly.
\n\tEnsure correspondence with authorities is handled (e.g. for permits, etc.) is handled effectively and timeously.
\n\tOversee and coordinate Lot Release preparations for launch batches, ensuring compliance with GMP, the registered dossier and prescribed procedures.
\n\tAttend and\/or present training sessions as and when required.
\n\tLiaise with 3rd\u00a0parties and internal stakeholders to ensure product realization is effectively coordinated.
\n\tEnsure stakeholder reporting is performed as and when the need arises.
\n\tEnsure that master data is maintained and kept up to date.
\n\tActively seek and implement continuous improvement activities to ensure that reporting team maintains a competitive industry advantage.
\n\tCoordinate and\/or prepare applications for PIT exemption for submission to SAHPRA.
\n\tEnsure that master data is maintained and kept up to date.
\n\tPerform any other duties as per operational requirements of the department.<\/p>\n
Good Manufacturing Practice<\/p>\n
\tMaintain all GMP principles in line with departmental Quality Management System and SAHPRA\/PICs GMP requirements.<\/p>\n
General<\/p>\n
\tPerform any other duties as per changes in operational requirements of the department.
\n\tEnsuring goals and objectives of direct report align with GIB departmental strategies.
\n\tAssist with Product Development and Product Technical Transfer projects.<\/p>\n
Requirements<\/p>\n
PRE-REQUISITES<\/p>\n
\tB.Sc. degree or equivalent scientific qualification.
\n\tMinimum of 1-2 years Regulatory hands-on experience, preferably within the pharmaceutical industry.
\n\tProven experience in quality assurance within the pharmaceutical industry, with a focus on new product launches (advantageous).
\n\tDetail-oriented with strong analytical and problem-solving abilities.
\n\tDemonstrated ability to drive continuous improvement and implement best practices in quality assurance.
\n\tStrong knowledge of regulatory requirements, including SAHPRA, Africa and international guidelines.
\n\tAble to perform all standard registration processes under specialist guidance.
\n\tExperience in other areas of pharmaceutical industry such as production and\/or analytical environment would be advantageous<\/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":{"0":"post-15434","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\/15434","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=15434"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=15434"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=15434"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}