A Pharmaceutical Company in Isando is looking for a QA Pharmacist with B Pharm degree and min 5 year experience in the industry who can ensure that the Company operates in compliance to the QA Management System, all of the provisions and regulations of the Medicine and Related Substances Control Act, Pharmacy Act and guidelines of cGMP pertaining to manufacture, warehousing and distribution of medicines and other health related products. Duties and Responsibilities will include: 1. Ensure applicant compliance with regard to licences, inspections, etc in terms of: Implementation and maintenance of a Quality Management System (QMS) incorporating Quality Risk Management, Corrective and Preventive Actions (CAPA), Deviations, Change Control, product complaints, Performance Measurement and Management Reviews. 2. Maintenance of the Applicant Site Master File 3. Self-inspections and self-inspection reports 4. Preparation in the event of a product recall 5. Ensure product compliance (batch release, master documentation) in terms of the following areas: - Review and approval of all artwork / advertisements / marketing material - Review and approval of all master documentation (validation master plans, stability protocols, master batch documents and other as required) - Review and approval of change controls, deviations and out of specification investigations - Review and approval of annual product reviews - Batch release procedures. - Management of import/export- and narcotic permits and annual returns of narcotic substances 6. Ensure Third Party compliance by: - Monitoring the implementation of the Supplier Approval and Re-evaluation process and reporting of any non-conformances - Assisting with the drafting and review of Technical Quality Agreements. 7. Risk management and reporting - Compile and generate reports around risk management to inform decision-making and business intelligence for the Regulatory and QA Department - Engage with the QA Department around areas of risk management in order to understand, manage and mitigate any areas of potential risk in terms of Regulatory and Quality Assurance compliance - Utilize statistical trend analysis, where applicable, in order to predict and mitigate risk.

Remuneration: Per Month, Employment Type: Full Time, Industry: Medical Pharmacist, Region: Gauteng/Isando, Company: Pharmaceutical Contractors

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Email to: LoraineB@pharmacon.co.za