Quality Lead: Quality Assurance

Company Description We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversified by geography, product and manufacturing capability. Aspen is a dynamic organization built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At Aspen, not only do we source for the best talent, but we also provide a host of opportunities for continuous development. The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines. Objective of Role The role undertakes responsibility for the oversight and management of the Pharmaceutical Tasks within the Quality Assurance division of the Quality department for Pharmacare Limited for all products marketed and distributed by Pharmacare (Pharmacare Ltd and Third-Party Partners), as delegated by the Responsible Pharmacist, ensuring compliance with sound QA principles, SOPs, Aspen Group and Third-Party Alliance partner policies and procedures and in accordance with GxP guidelines, The Pharmacy Act, Act 53 of 1974 as amended, the Medicines and Related Substances Act, Act 101 of 1965 as amended, and any other related legislation and guidelines relating to the import, export, manufacture, packing, testing, warehousing and distribution of medicines in South Africa and SADC, thereby ensuring that the products meet the intended quality, safety and efficacy standards and requirements as required of the MA holding entity, Pharmacare Limited. The role responsibility includes management of the Batch Release process for externally supplied products for Pharmacare Limited and Third-Party products, and management of the Stability and Vendor Management process for all Pharmacare Limited Products. Key Responsibilities General Operational Activities Adhere to agreed Key Performance Indicators (KPI) Support the continuous development and improvement of the Quality function while upholding Aspen core values Active collaboration with the regional and global quality, regulatory and operational teams to ensure the appropriate flow of information and decisions, to seek advice, inputs, guidance and work on any regional or cross functional projects Manage active collaboration and co‑ordination with internal and external business units, including the local Regulatory, Commercial and Operations teams to ensure the appropriate flow of information and decisions Effective management and utilization of resources to keep processes cost effective. Budget planning and management Collating data for ad hoc requests Ensure compliance with GxP for Manufacture, Testing, Storage, Distribution as well as compliance with applicable local regulations. Provide systems and SOPs implementation support for identified Pharmacare Departments/Divisions. Oversee all Applicant quality assurance activities as delegated by the Responsible Pharmacist. Keep abreast of developments in best practice, inspection trends and all QA related activities and maintain a high and up-to‑date level of QMS, QA, auditing, and therapy area of knowledge by attending conferences, training courses, reading relevant medical and scientific literature. Support with establishing professional working relationships with SAHPRA and other Regulatory Authorities Positive customer engagement Any other duties as assigned by line manager / HOD Quality Assurance Batch Release Responsibility for the Batch Release process (Outsource/CMO and Third‑Party Partners), including Post‑Importation Testing and related deviation and CAPA Management, in accordance with GxP requirements, Master documents and the registered product dossier Ensure that the Pharmacare Ltd‑Woodmead Responsible Pharmacist has oversight of all batches released to market Ensure that all required steps are followed in the batch release process as per the SOP Ensure appropriate management of post‑importation testing laboratories and associated reference standard management Ensure that any incidents that may impact product quality, safety or efficacy are escalated to the RA Manager: Quality and the Responsible Pharmacist for final decision and any regulatory action Ensure that a system is in place for QA evaluation and reporting of all product/batch related deviations to determine impact and recommended CAPA as well as effectiveness thereof. Ensure imported batches are tested within the agreed timeframe Ensure batches are released within agreed timeframe Management of blocked stock at the warehouses on a continuous basis Management of product reworks per SOP and GxP Management of Analytical method validation of Finished Product Management of Equipment Validation (OQ & PQ) and process validation including periodic validation Investigating and Resolving QA queries Ensure that feedback and/or reports on QA queries are conducted and requested from Outsourced GxP partner (CMO, Lab etc) and are discussed with QA management. Ensure appropriate follow‑up, logging, review and approval / rejection of all deviations (including Laboratory OOS), reports, etc Ensure appropriate handling and investigation of Suspect Stock Notifications to prevent recurrence Management of Raw Materials at CM as per SOP and assisting in resolving any queries on RM’s Ensuring SAP system is kept updated with regards to expiry date of stock, where applicable Temperature Excursions Ensure all forms of temperature excursions (pre- and post-release) are investigated and CAPA’s implemented Make decision on appropriate action and where required elevate to the RA Manager: Quality and the Responsible Pharmacist for final decision and any regulatory action Temperature Excursions to be trended and appropriate actions taken to prevent recurrence Product Stability Management Ensure that all marketed products are placed onto a stability programme as defined by a stability protocol Ensure there is a process in place to monitor stability data as it becomes available and to ensure that the product meets its registered stability specification at the specified storage conditions, in the specified container for the duration of the approved shelf Decide on appropriate course of action to be followed in the case of a stability alert and ensure escalation to management and Responsible Pharmacist, to agree on course of action Ensure stability commitments and special stability trials are actioned within the required timeframe Control of Highly Schedule Substances Ensure effective management and control of Highly scheduled products (S5 and above), according to relevant legislation and guidelines This includes requisitions, samples, registers, storage, permit management, reconciliations and submissions etc Ensure that any new products to be launched that will require a permit are setup with SAHPRA Conducting regular meetings with the logistics department to ensure that all S5 and S6 medicines coming into SA have the required permits Ensure Annual Returns are completed and submitted annually to SAHPRA before due date, end February QA Activities for NPL and Realignments Management of the QA activities for all New Product launches and realignments, ensuring that all activities are completed timeously so as not to delay launch PIT lab identification and setup (reference standards, columns and other materials), Analytical Method