Responsible Pharmacist

**Main Purpose of the Position**:
To act as a Responsible Pharmacist, ensuring compliance of Production facility, with all legislative provisions applicable to services relating to the scope of the business. To lead and manage the compliance function and its people, ensuring products are manufactured, packaged and quality assured according to client’s specifications and regulatory requirements, efficiently and effectively, thereby contributing to the organization’s strategic objectives.

**Experience and Competencies required**:

- Degree B Pharm - NQF Level 9 or higher.
- Registration with the SAPC as a Pharmacist
- Minimum of 5 years’ experience in Pharmaceutical Production in a senior management role
- Minimum of 5 years’ line management experience
- Minimum of 5 years’ experience as a Responsible Pharmacist within Production
- Strong systems, process, and best practices experience
- Excellent communication skills (Written & Spoken)
- Problem solving Skills.

**Key Responsibility Areas**:
**Responsible Pharmacist**:

- Responsible for compliance with technical and regulatory requirements related to the quality of finished products and the approval of the release of finished products for sale.
- Responsible to the South African Pharmacy Council for compliance with the provisions of the Pharmacy Act (Act 53 of 1974)
- Be responsible to SAHPRA for compliance with the provisions of the Medicines and Related Substance Act, 1965 (Act 101 of 1965) relating to the sale, control of the manufacturing and distribution of medicines, schedule substances or medical devices.
- Continuous Supervision of every Pharmacist and Pharmacist assistant appointed by the company
- 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.
- Not introduce or carry out and instruction or order with regard to the Pharmacy business of the pharmacy owner which could amount to contravention of legislation applicable to such Pharmacy business.
- Ensure that no person is appointed to perform any act falling outside of the scope of practice of the category in which such person is registered or which he/she is not authorized to perform in terms of the Pharmacy Act, 1974 (Act 53 of 1974)
- Initiate and co-ordinate all recall and withdrawal activities, which should involve the Head of Quality.
- Ensure compliance with the requirements of the Medicines and Related Substances Act, 1965 (Act 101 of 1965)
- Ensure that all employed Pharmacist are appropriately registered with the South African Pharmacy Council.
- Notify the Pharmacy Council immediately upon receiving knowledge that your services as Responsible Pharmacist have been or will be terminated.
- Ensure that there is compliance with Good Pharmacy Practice as published by the Pharmacy Council
- Take corrective action in respect of deficiencies with regard to inspection reports of Pharmacy Council or in terms of the Medicines Act.
- Ensure the safe and effective storage and keeping of medicines or scheduled substances in the Pharmacy under your direct personal supervision.
- Ensure corrective and effective record keeping of the purchase, sale, possession, storage, safekeeping, and return of medicines and scheduled substances.
- Inform Contract Givers immediately of any (Customer complaint, OOS) investigations that indicate the possibility of a recall. Prepare investigative reports and discuss with the Applicant the process of notification to SAHPRA and immediate actions to be taken to manage the situation. Attend SAHPRA recall discussions and meetings with the Applicant.

**Strategy & Planning**:

- Assist in formulating the company's future direction and supporting tactical initiatives.
- Develop, monitor, and direct the implementation of the strategic business plans for Operations to meet growth targets.
- Develop the operational plans for Compliance & Operations
- Plan specific Compliance & Operations projects.
- Develop performance measures for Compliance & Operations

**People Management**:

- Establish clear directions, set objectives, distribute the workload appropriately, lay out work in a well-planned and organized manner for direct reports.
- Monitor and manage performance against objectives as per the Performance Management Process
- Maintain two-way dialogue with direct reports through ongoing discussions and hold regular planned meetings to discuss progress and objectives.
- Identify and implement training and development needs for direct reports; as training needs are identified and formally during the performance review and appraisal discussions.
- Attract and retain talent within Quality and Compliance
- Develop Succession Plans for key roles and talent within Quality.

**Budgets and Forecasts**
- Develop operational and CAPEX budgets for Technical Operations
- Develop Technical Operations forecast.

**Corporate Governance**
- Ensure that Quality complies with all legal and regula