Tafadzwa Mtambanengwe

Company Compliance

• Responsible for overall company compliance to SAPC/SAHPRA/DOH legislation.
• Ensuring applicant operates in accordance with provisions of the Medicines and Related Substances Control Act, The Pharmacy Act and other applicable national legislation.
• Ensuring compliance with all printed packaging material and promotional material.
• Responsible for SOP implementation, update and compliance.
• Ensuring products released to market comply with approved registration dossier and quality control parameters.
• Ensuring that company SOPs, Quality Manual and Site Master File are kept updated.
• Ensuring processes and systems are in place for SAHPRA and SAPC inspections.
• Ensuring personnel are adequately trained, and training records are available for inspection.
• Ensuring batch manufacturing and master documentation review and approval prior to production taking place.

Product Registration

• Responsible for screening, compilation and submission of new registration applications to SAHPRA.
• Response to address pre-registration evaluation queries from SAHPRA.
• Responsible for variation submission to SAHPRA.
• Responsible for renewal submissions to SAHPRA.
• Ensure on-going regulatory compliance of existing product portfolio.
• Ensure awareness of legislative changes and trends that will impact core functions of the regulatory affairs department.
• Ensuring that the company is aware of significant local regulatory issues which can impact the business.
• Submission of dossiers/variations via Docubridge eCTD management software.

Document Management

• Managing and maintaining regulatory documentation management system.
• Ensuring regulatory compliance and quality related records are available and retained.
• Ensuring there is up-to-date database of all submissions made in the Territory indicating the status of each application.
• Providing weekly and monthly status reports to the Chief Business Development Officer and CEO on the status of projects.

Pharmacovigilance

• Qualified Person Responsible for Pharmacovigilance.
• Responsible for receipt, review and response to all adverse drug reactions.
• Maintenance of the Pharmacovigilance System Master File.

Quality Assurance Responsibilities

• Maintaining of an effective Quality Management System supporting Quality Department with all quality control, quality assurance and regulatory compliance activities
• Training champion responsible for the organization's training activities
• Assisting in management of Product Complaints ensuring effective Corrective and Preventative Actions (CAPA) preventing recurrences
• Initiation and management of follow through CAPAs and effectiveness checks as per deviation procedure
• Initiation and management of change controls
• Compilation of Quality reports for Quality Management Review meetings
• Assisting with review of Product Quality Reviews received from Manufacturer
• Assisting Procurement with Vendor Management (conducting vendor qualification and maintaining approved vendor list) to ensure compliance with GMP
• Drafting and maintenance of Quality Technical agreements with vendors
• Conducting internal and external audits according to the audit program
• Assisting with Quality Risk Management including verification of risk mitigation implementation in products and processes
• Assisting in writing, reviewing and maintenance of the organization's standard operating procedures
• Responsible for maintenance and control of Master Documentation as per organizational procedures

Regulatory & Deputy Responsible Pharmacist duties

• Ensuring compliance with statutory/regulatory requirements of various authorities such as SAHPRA, SAPC in South Africa and related regulatory authorities in other Africa Countries where products are sold
• Compliance with international quality standards and systems
• Liaising with regulatory authorities and industry forums
• Screening and proof reading of documentation for legal compliance
• Ensuring the appropriate licensing, marketing, and legal compliance of veterinary products in order to control the safety and efficacy of products
• Attending relevant meetings/seminars in order to ensure updated knowledge of regulatory legislation and guidelines RSA, SADC and International
• Preparing submissions of new product applications, variations, and renewals
• Updating dossiers including conversions to CTD
• Maintaining registration dossiers
• Maintaining API/ Chemical files for registration
• Monitoring and setting timelines for registration variations and renewal approvals
• Compiling special applications for import of unregistered medicines to be submitted to the regulatory authorities
• Advising scientists and manufacturers on regulatory requirements
• Providing strategic regulatory advice to senior management throughout the development of a new product
• Attending monthly Technical Meetings and others as advisor
• Establishing appropriate communication with other departments, manufacturers and 3rd parties supplying information for registrations
• Liaising with local and overseas manufacturers or suppliers for product compliance
• Reviewing product artwork and promotional material for technical compliance
• Participating in regulatory audits
• Acting as a Deputy Responsible Pharmacist in the absence of the Responsible Pharmacist.

• Department Head managing Supervisors, Line Leaders, and Operators
• Ensuring Good Manufacturing Practice throughout the factory Improving productivity in process streams within the Soft Gel and Liquid Manufacturing
• Opening and Closing of Production Lines
• Writing and compilation of SOPs within the facility
• Training of personnel on SOPs and ensuring SOPs are implemented effectively
• Ensuring that all Dispensary orders are checked and signed for on the issue of materials to process production streams
• Checking and Signing of Bulk Manufacturing Tickets and Packaging Tickets
• Checking on weighing of raw materials prior to manufacture
• Reporting non-conformances within the production streams, conducting investigations and compilation of deviation reports
• Compilation of Corrective Action Preventive Action to address deviations within the facility
• Initiation of change control to improve production streams
• Conducting customer complaint investigations, determining root causes, and implanting corrective and preventive actions
• Formulation adjustment and improvement in liaison with New Product Development
• Ensuring good safety practices are adhered to within the factory
• Participation in third-party and regulatory audits
• Initiation of reworks/process adjustments within production
• Signing off Manufacturing Instructions or additions to current batches
• Reconciliation of bulk manufacturing and packing batches

• Determining the indication, efficacy and safety of drug therapy and ensuring that it meets the patient's medicine related needs
• Acting within the legal requirements of the SAPC when interpreting and dispensing Medication
• Liaising with the medical aids for patient chronic medication applications
• Pharmaco-therapeutic advice to patient's to ensure effective drug therapy and management of diseases
• Provision of pharmacist-initiated therapy Stock control and management
• Management of patient profiles and proficiency with the UNISOLV system Staff forecasting
• Budget and finance management of the dispensary SOP implementation within the team
• Conflict Management and Resolution Training of pharmacy personnel

• Ensuring manufacture of complimentary medicines is according to GMP standards
• Compilation and review of SOPs
• Drafting a Quality Management System of a complimentary medicine factory
• Performing Internal Audits of all departments of the factory and ensuring that the necessary corrective actions are implemented to ensure that QMS and GMP standards are consistently met
• Training of personnel on SOPs and ensuring SOPs are implemented effectively
• Quality Assurance on all complimentary medicines manufactured
• Assessment of bulk manufactured and ensuring that production targets are met
• Complete and sign off bulk manufacturing documents and the packaging documentation when the Responsible Pharmacist was absent
• Problem-solving and implementation of corrective-action preventative - action
• Acting Responsible Pharmacist (when RP is absent)