Responsible PharmacistThe Responsible Pharmacist is to ensure that all pharmaceutical and related activities undertaken and/or under consideration are according to licenses and legislation as well as any corporate guidelines. The suitable candidate will take full responsibility for all pharmaceutical actions taking place in the Sterile Manufacturing unit and are compliant according to national / international cGMP Guidelines, and will be based in Midrand, Gauteng.Duties & ResponsibilitiesRegulatory and Licence ComplianceTo liaise with the SAPC in terms of statutory compliance and to ensure Good Manufacturing Practice and Good Pharmacy Practice in the Sterile Manufacturing Unit.To undertake the overall administration of the pharmacy business, as described in Section 25(1) of the Pharmacy Act of 1974.Responsible to SAHPRA for compliance with the requirements of the Medicines and Related Substances Act, 1965 (Act 101 of 1965).To liaise with SAHPRA in terms of regulatory compliance, registration of medicine and final product, pharmacovigilance, and complaints.Ensure GMP and Good Laboratory Practice (GLP) compliance from suppliers and contracted laboratories.Ensure that persons being employed at the company and who provide services forming part of the scope of pharmacy practice of a pharmacist are appropriately registered with the South African Pharmacy Council.Notify the Pharmacy Council immediately upon receiving knowledge that his/her services as responsible pharmacist have been or will be terminated.Take corrective measures in respect of deficiencies with regard to inspection reports of the Pharmacy Council or in terms of the Medicines Act.Ensure that a letter of authorisation to communicate with Council, signed by the GM/CEO, be submitted to SAHPRA.Control the manufacturing or distribution of medicines, scheduled substances or medical devices in terms of the provisions of the Medicines Act, 1965.Be part of the decision-making process affecting the pharmacy business.Does not introduce or carry out any instruction or order of management with regards to the pharmacy business of the pharmacy owner which could amount to a contravention of legislation applicable to such pharmacy business.Ensure that the directors of the company comply with all the conditions of ownership of such a pharmacy business.Ensure that no person is appointed to perform any act falling outside the scope of practice of the category in which such person is registered or which he/she is not authorised to perform in terms of the Pharmacy Act, 1974 (Act 53 of 1974).Report in writing any non-compliance with the Pharmacy Act to the management of such pharmacy business and furnish Pharmacy Council with a copy thereof.Ensure continuous registration of the pharmacy with the statutory bodies.To facilitate programmes of Continuing Professional Development for all pharmacists.To ensure regulatory compliance with respect to procurement, storage, distribution and correct disposal of all medicinal and medical products.To co-ordinate training (if applicable) of Pharmacist Assistant with an accredited Service Provider for all admixing and supportive staff.To assess and approve all customers for compliance with statutory and regulatory requirements.To purchase and maintain the latest up to date Reference Books as stipulated by SAPC.Ensures that all activities undertaken or proposed to be undertaken are in compliance with legislated requirements and in compliance with corporate guidelines.Implement corrective action from SAHPRA and/or Pharmacy Council inspections and or corporate audits.Quality ComplianceTo review Quarterly Risk Reports.To oversee the implementation of a Quality Management System.To oversee the SOP process and approve all written procedures pertaining to the scope of practise of a pharmacist as set out in Act 53 of 1974.To oversee that processes needed for the Quality Management System are established, implemented and maintained.To oversee annual Management Reviews.To manage all product complaints by ensuring that they are reported on in-house database on time and to follow up regularly with respect to responses to such complaints.To oversee the preparation of Product Quality Reviews (PQR) of all final products.To ensure that Quality agreements are in place with all suppliers of product and critical services.To oversee inspections of all suppliers of product and services which have an impact on Quality.To oversee the assessment of all distributors and transporters for compliance as per SLA with the service provider.To promote the awareness of customer requirements throughout the company.To establish a culture of continuous training within the company and to ensure proper documentation of such training.To ensure that Technical Agreements are in place with all suppliers and distribution companies.Sterile Product and Facility ComplianceTo manage and ensure smooth functioning of the Aseptic Services Unit, ensuring compliance to cGMP and specific requirements of SAHPRA as stated in the License to Manufacture.Ensure correct use and maintenance of all ASU equipment.Conduct periodic research on products being mixed in the ASU with respect to validation of Processes, Stability and other components.Ensure adherence to occupational health and safety requirements.Staff Management and TrainingEnsure co-operation between quality and production staff.Ensure personnel have the correct education, training and experience to perform the assigned function.Assess staff competency as well as co-ordinate and facilitate training of staff.Implement disciplinary action where required.Oversee training of cGMP and other compliance training for all new and existing staff as required.Ensure a robust training system is in place that ensures compliance with cGMP.BudgetsManage Capex, expense and CASH-flow budgets.Endeavour to achieve annual budgets and production target.GeneralTo represent the company at various Professional Associations e.g. ISPE, PDA, PSSA, SAAPRA, SAAHIP, SAAPI.Stock ControlOversee the stock control process.Ensure monthly cycle counts are performed.Ensure annual stock take is performed in line with Head Office requirements.Ensure adequate stock levels are maintained.ProductionWill be responsible for the final release of all products produced inside the ASU.Implementing of best practices, designed to develop and improve manufacturing efficiency.Oversee all the production processes inside the ASU.Assist in conducting audit activities to ensure compliance with all licence conditions and GMP rules and regulations.Desired Experience & QualificationB.Pharm DegreeManagement trainingDesired Work ExperienceAt least five years' experience in Pharmaceutical industry.Two to three years management level experience with experience in leading and managing a Quality team and/or Production team, with proven track record.Management of Projects within the pharmaceutical industry advantage.
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