Reference: CPT000390-CH-1 The QA Manager and Deputy Responsible Pharmacist will manage, maintain and enhance the South Africa Quality Management System to be SAHPRA inspection-ready at all times and assume all the responsibilities of the Responsible Pharmacist in their absence. Product Releases : Ensure QA release of products as per the QA Release SOP, clearly stating the release as per the QA Release Masters. Responsible to ensure that only quality products are released into the market. Ensure that at least one executed batch record per product is reviewed annually as part of the QA release process. Ensure that the batch documents reviewed communicates the correct formulation, method of manufacturing, artwork material and registered sites as per current approved dossier. Ensure that the approved manufacturer of the API was used. Ensure during the QA release process that the COA's are in line with the registered product specifications. Work very closely with the Regulatory Affairs team to ensure that products released are in line with current registered parameters, especially when there have been recent changes to registered information. Support Supply Chain team to ensure the timely release of quality products into the market. Ensure that retention and release samples are kept of all product batches released to market. Quality Management Processes: Manage all final product manufacturers (local and via the regional office), final product release laboratories, packers, warehouses and distributors of products, and confirm that they have quality systems in place to ensure high quality products. Ensure that all manufacturers, laboratories, packers, warehouses and distributors of products have the necessary GMP Certificates, Manufacturing Licenses and Site Master Files in place. Manage the local GMP Audit program and conduct external audits and self-inspections as per the GMP Audit Schedule, to ensure that systems are in place to maintain the positive GMP status of all sites. Also oversee that global audits are performed by the Group QA team as per Audit Schedule, and that audit reports and responses are shared with South Africa. Ensure that Quality Technical Agreements are in place for all sites utilised for products, and that these are maintained as per revision register. Manage the Change Control process and facilitate and capture all change controls and communicate to all the relevant stakeholders. Manage and implement the Change Control software system (Veeva Electronic Document Management System). Coordinate monthly Change Management meetings. Manage all Deviations (both internal and from external suppliers) as per approved processes. Manage and record all technical product quality complaints (PQC's) or queries and customer returns, with the relevant stakeholders. Complaints to be trended to identify recurring issues or ineffective CAPA's Implement the required corrective and preventative actions (CAPA), conduct the necessary quality/technical investigations and ensure that all QA/technical related matters are solved in a timely manner. Ensure that all CAPA's raised out of an external audit are managed according to the time frames allocated to them. Participate in process improvement and product investigations. Manage and roll-out stability programs per product, per annum, and confirm that our products are stable throughout the approved shelf life. Ensure that analytical methods are validated as per GLP requirements. Ensure that test method transfers/verifications/cross-overs are performed for all products that are tested post-importation in South Africa. Ensure that Product Quality Reviews are available and completed per annum as per schedule. Lead technology transfers of all products when needed. Implement and maintain the necessary Quality Systems and ensure that SOP's are guiding all personnel in a clear and understandable manner. Ensure that all QA SOP's are updated as per renewal schedule. Communicate in a timely fashion, all information regarding formulation changes, project status, results, etc. to all appropriate individuals (QA, RA, Marketing, Supply Chain, EXCO etc.). Support the Responsible Pharmacist during product recalls and ensure that one Mock Recall is performed per year (in the absence of an actual recall). Ensure that at least one Quality Management Review Meeting is performed per year. Always apply Risk Management principles in the QA department and adhere to all risk management processes. Lead technical problem-solving initiatives (including any investigations and correction of product stability failures). Administrative and other responsibilities: Manage the relevant permit applications and Custom's clearance forms and complete the SAHPRA annual return for Specified Schedule 5's on time. Preparation of a detailed monthly QA Report to capture all quality related activities. Represent the Quality Department as part of a cross functional team to ensure the delivery of projects (e.g. product launches etc.) into production with the highest level of quality, compliance and adherence to timelines. Keep abreast of current trends, practices, developments and regulatory changes which would impact of products. Assist with the management of the costs of the analysis in the laboratories and ensure the availability of reference standards, unique columns and equipment. Investigate more cost-effective ways to release our products. Act as the local VEEVA Administrator for South Africa and arrange training for all local users. Ensure that the QA SharePoint site is maintained appropriately in good order, and that all local trackers (where applicable) are updated and kept current at all times for accurate reporting. Ensure effective collaboration with the Regulatory, PV and Supply Chain teams for the benefit of the business Requirements: Tertiary qualifications in Pharmacy Registration with the South African Pharmacy Council Minimum of 1-year production experience is advantageous. Minimum of 4-years Quality Assurance experience (preferably with a Multinational). Minimum of 2-years' experience in a management role. Experience/exposure to Regulatory Affairs is a recommendation. Excellent project management skills. Well-developed problem solving and analytical skills. Excellent written and verbal communication skills. Attention to detail. Well-developed interpersonal skills, negotiation skills and customer focus. Ability to work well in a team environment. Ability to multi-task and prioritise in a high-pressure environment. Building and managing people capability and driving and rewarding excellence. Ethics, integrity and commitment. Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com Should you receive no feedback within 7 days, please accept your application as unsuccessful. Related Apply Now

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QA Manager & Deputy Responsible Pharmacist - Gauteng

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