Responsible Pharmacist

Responsible Pharmacist required in Germiston.

Manage and maintain the Pharmaceutical operation as per the requirements of SAHPRA, SAPC, the company and the clients as well as manage the quality management system (QMS) documentation, records, processes and procedures.

Salary: R30K – R55K per month.

Duties and Responsibilities:

General:

• 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.
• Managing all Corrective and Preventive Actions (CAPAs) resulting from audits 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 facilitating QMS meetings.
• Maintaining all QMS documentation and filing.
• Preparing and scheduling the Management Review Meetings.
• Administrative tasks.
• Carrying out general housekeeping within the work environment.

Pharmaceuticals:

• Must be registered as a pharmacist with SAPC.
• Liaising with the SAPC in terms of statutory compliance and ensuring Good Wholesaling and Distribution Practice, Good Pharmacy Practice and Good Distribution Practice in the Warehouse.
• Ensuring correct licensing of the warehouses and payment of the annual license fee to the SAHPRA for continued registration.
• Notifying SAHPRA of any changes to licensing conditions and Site Master File.
• Ensuring that a pharmacist continuously supervises the wholesale pharmacy (warehouse operation).
• Responsible for the effective, efficient and safe handling, storage and distribution of products.

Controlling access to Scheduled products, medical devices or IVDs and ensuring that products are delivered only to licensed/registered entities as managed by customers.

• Ensuring contracts exist between the Client (contract giver) and the company (contract acceptor) stipulating where all the responsibilities in terms of GWP lie.
• Ensuring contracts with any third-party distributors are in place.
• Maintaining Service Level Agreements (SLAs) with providers of a service that may have an impact on the quality of a product.
• Ensuring that all clients possess the necessary licenses that the pharmaceutical products, medical devices or IVDs are from a legitimate source and registered with the SAHPRA.
• Ensuring regulatory compliance with respect to procurement, storage, distribution and correct disposal of all medicinal and medical products.
• Maintaining strict storage control and documentation with respect to Schedule 5 and 6 products.
• Purchasing and maintaining the latest up-to-date Reference Books as stipulated by SAPC.
• Ensuring that all products imported on behalf of a client are sampled as per client instructions and retention samples kept where necessary.
• Assessing any third-party distributors and transporters for compliance.
• Reporting to Management on any need for improvement.
• Acting as Pharmacovigilance Responsible Person for the Company.
• Assuming primary responsibility for receiving any Adverse Drug Reactions (ADRs) on behalf of the client and speedy onward forwarding thereof.
• Managing and ensuring smooth functioning of the Pharmaceutical Warehouse, ensuring compliance to GWP and GDP.
• Overseeing 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.
• Ensuring adherence to occupational health and safety requirements.
• Documenting any out of limit situation and reporting to QA Manager.
• Ensuring that all personnel working within the pharmaceutical storage areas have the correct education, training and experience to perform the assigned function.
• Controlling access to restricted pharmaceutical storage areas outside of normal trading hours.
• Ensuring that the key to the restricted pharmaceutical storage area is controlled by the pharmacist.
• Keeping correct and effective record keeping of the receipt, possession, storage, safekeeping and return of pharmaceutical products.
• Participating regularly in continuing professional development (CPD) programmes.
• Ensuring another pharmacist or locum is available in the wholesale pharmacy in the absence of the Responsible Pharmacist.
• Ensuring 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.

Training:

• Planning, scheduling and conducting training on QMS procedures.
• Management of training records in line with company procedures.

Audits:

• 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.

Requirements:

• Matric / Grade 12.
• Qualified and registered Pharmacist with ISO 9001 knowledge.
• Minimum 2 – 3 years’ experience with ISO 9001 Quality Systems Management and auditing.
• Valid SA Driver’s Licence and own vehicle.
• Willing to work after hours if necessary.
• Warehousing experience beneficial.