Job Description

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 regulatory requirements, codes, rules, and standards.

Prepare and present Quality Reports for the Board

Risk Management:

Understand and mitigate key elements of Quality's risk profile.

Construct and monitor reliable control systems.

Report risk issues to the audit committee

Quality:

Maintain a Quality Management System (QMS)

Ensure product quality meets regulatory and client requirements.

Identify and implement continuous quality improvement initiatives.

Prepare and implement project plan for Therapeutic Goods Administration (TGA - Australia) approval.

Supplier Management

Manage supplier information as per requirements.

Ensure that current supplier credentials; BBBEE certificate, tax certificate are provided to Finance for BBBEE status for audit purposes.

New Business Development

Develop and advise on business development for new business opportunities.

Provide expertise and support for acquisition due diligence and the negotiation of acquisitions

Stakeholder Management

Develop and implement a stakeholder strategy to build and manage relationships with stakeholders.

Batch Releases:

Delegate the authority to QA Pharmacist in writing to perform product release activities. To ensure that batches are released in accordance with batch release procedure. To release batches in accordance with batch release procedure in the absence of the QA Pharmacist. To ensure before batches are released, that the batches comply with the registered dossier requirements/certificate of registration. To ensure that each batch product released has been manufactured, tested, and/or packed is in compliance with section 19 of medicine Act. To liaise with relevant departments to resolve product or process related quality issues in order to facilitate batch release, where applicable. The release parameters on the COA provided by QA are all within specification and the COA is signed by the QC Section head and QC Manager To review all applicable production, quality control and quality assurance documentation to ensure that all necessary steps have been taken, recorded and endorsed by authorize persons. To ensure that any deviations from approved procedures, method and or/ expected results have been authorized by the relevant persons. To ensure that samples are drawn during production including QC, release, retention and/or customer samples, as specified by the relevant production batch.
Job Type: Permanent

Work Location: In person