About the Position
Manage and maintain the Pharmaceutical operation as per the requirements of SAHPRA, SAPC, Value and the clients as well as manage the quality management system (QMS) documentation, records, processes and procedures.
Role and Responsibilities:
- Maintaining the certification against the ISO 9001 standard as well as the respective licenses required for pharmaceuticals and medical related products.
- Implementing, managing and maintaining all procedures required for a successful QMS system as required by the respective standards and regulations.
- To manage all Corrective and Preventive Actions (CAPAs) resulting from audits in order to ensure their satisfactory conclusion.
- Compiling all QMS related reports.
- Providing feedback to management on the QMS.
- Identifying corrective actions and improvement opportunities in the operation.
- Promotion of the QMS and the awareness thereof within the business.
- Setting up and facilitation of QMS meetings.
- Maintain all QMS documentation and filing.
- Preparation and scheduling of the Management Review Meetings.
- Administrative tasks.
- Carrying out general housekeeping within the work environment.
- Must be registered as a pharmacist with SAPC.
- Liaise with the SAPC in terms of statutory compliance and to ensure Good Wholesaling and Distribution Practice, Good Pharmacy Practice and Good Distribution Practice in the Value Logistics Warehouse.
- Ensure correct Licensing of the Value Logistics warehouses and to ensure payment of the annual license fee to the SAHPRA for continued registration.
- Notify SAHPRA of any changes to licensing conditions and Site Master File.
- Ensure that a pharmacist continuously supervises the wholesale pharmacy ( warehouse operation).
- Be responsible for the effective, efficient and safe handling, storage and distribution of such products.
- Control the access to Scheduled products, medical devices or IVDs and ensure that product is delivered only to licensed / registered entities as managed by Value customers.
- Ensure that contracts exist between the Value Client (contract giver) and Value Logistics (contract acceptor) stipulating where all the responsibilities in terms of GWP lie.
- Ensure contracts with any third-party distributors are in place
- Ensure and maintain Service Level Agreements (SLAs) with providers of a service that may have an impact on the quality of a product
- Ensure that all Value clients are in possession of the necessary licences that the pharmaceutical products, medical devices or IVDs are from a legitimate source and registered with the SAHPRA
- Ensure regulatory compliance with respect to procurement, storage, distribution and correct disposal of all medicinal and medical products.
- Ensure that strict storage control and documentation is kept with respect to Schedule 5 and 6 products.
- To purchase and maintain the latest up to date Reference Books as stipulated by SAPC.
- To ensure that all products imported on behalf of a Value client are sampled as per the client instructions and retention samples kept where necessary.
- To assess any third-party distributors and transporters for compliance.
- To report to Management on any need for improvement
- To act as Pharmacovigilance Responsible Person for Value Logistics
- To assume primary responsibility for the receiving of any Adverse Drug Reactions (ADRs) on behalf of the client and speedy onward forwarding thereof
- To manage and ensure smooth functioning of the Pharmaceutical Warehouse, ensuring compliance to GWP and GDP.
- To oversee all functions related to inventory control, including receiving, storage, quarantine, picking and packing, cycle and annual stock counts etc, where Pharmaceutical or Medical products are concerned.
- Ensure adherence to occupational health and safety requirements.
- Ensure documentation of any out of limit situation and report to QA Manager.
- Ensure that all personnel working within the pharmaceutical storage areas have the correct education, training and experience to perform the assigned function
- Ensure that unauthorised persons do not obtain access to restricted pharmaceutical storage areas outside of normal trading hours.
- The key to the restricted pharmaceutical storage area must be controlled by the pharmacist
- Ensure correct and effective record keeping of the receipt, possession, storage, safekeeping and return of pharmaceutical products.
- Participate regularly in continuing professional development (CPD) programmes;
- Make certain that another pharmacist or locum is available in the wholesale pharmacy in the absence of the Responsible Pharmacist.
- Ensure that all reference sources required in accordance with Regulation 1.2 “Minimum Standards for Pharmacy Premises, Facilities and Equipment” of the Pharmacy Act are on hand.
- Planning, scheduling and conduct training on QMS procedures.
- Management of training records in line with company procedures.
- Planning and conducting internal quality audits as required.
- Management of audit close outs and actioning.
- Liaising with auditing and regulatory bodies on audit schedules and requirements.
- Management, preparation and involvement in customer audits.
- ISO 9001 Knowledge.
- At least 2-3 years ISO 9001 quality system management experience.
- ISO 9001 auditing experience.
- Administrative skills.
- Organisation skills.
- Computer literate.
- Good communication skills.
- Training skills.
- Interpersonal skills.
- Well presented.
- Hard working.
- Positive attitude.
- Have a sense of urgency.
- Detail oriented.
- Have knowledge and understanding of the functioning of operations and systems within the Value Group.
- Have knowledge and understanding of all the Standard Operating Procedures pertaining to their function.
- Have knowledge and understanding of Value policies.
- Knowledge of Health and Safety procedures and policies applicable to own work area.
- Have knowledge and understanding of the ISO 9001 standard and processes.