Reference: CPT000389-CH-1 A global pharmaceutical company is seeking a Quality Assurance Pharmacist. Verify products against the QA release masters to ensure that quality products are release for sale Assist on the facilitation of change controls Assist on artwork and related projects Implement and manage a Pharmacoviligance system compliant to local health authorities and the Company's global requirements. Detect, assess, understand, and prevent adverse events. Facilitate medical queries Product lead ensure that the dossier is compliant and in line with the registration certificate. Communicate technical issues or shortcomings to stakeholders and in the correct format. Manage all Final product manufacturers, Final Release Laboratories, warehouse and distributors or implement quality systems to ensure quality products Ensure that all Manufacturers, Laboratories, Warehouses and Distributors have the necessary GMP certificates, Manufacturing Licenses and Site Master Files in place Conduct external audits to ensure that systems are in place to maintain the positive GMP status of all Manufacturers, Laboratories, Warehouses and Distributors Ensure that Quality/Technical agreements are in place for all our products Manage and facilitate artwork projects with the different stake holders and ensure that our product's artwork reflect the correct information as per the current product dossier and legislation. Manage and maintain the relevant artwork master files. Manage bar codes and nappi codes QA release products as per the QA release SOP, clearly stating the release as per the QA release masters. Confirm that only quality products are released in to the market Ensure that the batch documents reviewed during the QA release process communicate the correct formulation, method of manufacturing. Confirm that the process is validated. Ensure that the correct manufacturer of the API was used. Update specifications and indicate the different phases of the product, in-process, release and shelf life and analytical methods if required and confirm that the method validation is as per GLP requirements. Ensure during the QA release process that the COA's are in line with the products specifications Manage and role out stability programs per product, per annum and confirm that our products are stable throughout the shelf life Ensure that Product Quality Reviews are available per annum. Manage and record technical, quality related queries and customer returns with the relevant stakeholders Implement the required corrective and preventative actions, conduct the necessary quality/technical investigations and ensure that the QA/technical related matters are solved in a timely manner Implement and maintain the necessary Quality Systems and ensure that the SOP's are guiding all personnel in a clear and understandable manner Support supply chain to ensure the timely release of quality products in to the market Manage the relevant permits and complete the annual returns in a timely manner Facilitate with regulatory and if required apply for once off batch applications Manage the costs of the analysis in the laboratories; ensure the availability of reference standards, unique columns and equipment. Investigate more cost effective ways to release our products Facilitate and capture all change controls and communicate to the relevant stake holders. Manage and implement the required change control software systems Capture all technical and quality related matters in the relevant reports and communicate to all stake holders to enable accurate reporting Report ADE's Manage PSUR and communicate to all stake holders Complete MCC returns Complete Custom's clearance forms Requirements: Tertiary qualifications in pharmacy Registration with the Pharmacy Council, South Africa Minimum 1 year production experience. Minimum 2 years quality assurance experience (preferably with a multinational). Experience/exposure to Regulatory Affairs is a recommendation. Experience/exposure to pharmacovigilance and clinical work is a recommendation. Good 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. 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. Apply Now

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Quality Assurance Pharmacist - Gauteng

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