Responsible Pharmacist

Overview

• A leading organisation within the pharmaceutical manufacturing industry is seeking a highly experienced and professionally registered Responsible Pharmacist to oversee pharmaceutical operations, regulatory compliance, medicines control and quality governance at its Clayville facility.
• The successful candidate will be responsible for fulfilling the statutory and professional obligations of the Responsible Pharmacist, ensuring that all pharmaceutical activities comply with the Pharmacy Act, Medicines and Related Substances Act, South African Pharmacy Council SAPC requirements, South African Health Products Regulatory Authority SAHPRA requirements, and applicable Good Manufacturing Practice GMP and Good Pharmacy Practice GPP standards.
• This role requires strong pharmaceutical manufacturing experience, comprehensive regulatory knowledge and the ability to provide independent oversight of activities affecting medicine safety, product quality, efficacy and regulatory compliance.
• The successful candidate must demonstrate sound professional judgement, strong leadership capabilities and the confidence to challenge, stop, reject or escalate activities that may compromise patient safety, product quality, medicines control or regulatory compliance.

Key Responsibilities Responsible Pharmacist Governance & Regulatory Compliance

• Fulfil all statutory and professional responsibilities associated with the Responsible Pharmacist appointment.
• Ensure the licensed pharmaceutical facility operates in accordance with applicable legislation and regulatory requirements.
• Maintain compliance with the Pharmacy Act and Medicines and Related Substances Act.
• Ensure adherence to SAPC requirements and SAHPRA licence conditions.
• Maintain compliance with applicable GMP and GPP requirements.
• Provide independent pharmaceutical oversight of operations and activities affecting product quality and patient safety.
• Ensure the implementation and maintenance of appropriate pharmaceutical governance controls.
• Monitor compliance with regulatory obligations and licence requirements.
• Identify and escalate significant pharmaceutical, quality and regulatory risks.
• Exercise appropriate professional authority to challenge, stop or reject non-compliant activities.
• Ensure statutory Responsible Pharmacist obligations are consistently fulfilled.

Regulatory Authority Engagement & Inspection Management

• Act as the primary liaison with SAPC, SAHPRA and other relevant regulatory authorities.
• Manage regulatory interactions relating to pharmacy practice and pharmaceutical facility compliance.
• Coordinate and support regulatory inspections.
• Ensure the facility maintains appropriate inspection readiness.
• Manage regulatory compliance commitments and follow-up actions.
• Respond appropriately to regulatory observations and findings.
• Ensure reportable events are communicated to the relevant authorities where required.
• Maintain accurate regulatory documentation and correspondence.
• Monitor regulatory compliance risks and escalate significant concerns.
• Support effective implementation of corrective actions arising from regulatory inspections.

Pharmaceutical Staff Supervision & Delegation

• Supervise pharmacists and pharmaceutical personnel performing activities requiring pharmacist oversight.
• Ensure appropriate professional supervision of pharmaceutical operations.
• Establish and maintain formal delegation systems.
• Ensure delegated pharmaceutical activities are performed by appropriately authorised and competent personnel.
• Monitor compliance with applicable pharmacist supervision requirements.
• Provide guidance on professional and regulatory obligations.
• Ensure appropriate accountability and oversight of delegated responsibilities.
• Support the development of pharmaceutical compliance capabilities.
• Promote professional conduct and adherence to regulatory requirements.

Medicines & Scheduled Substance Control

• Maintain oversight of medicines and scheduled substances within the licensed pharmaceutical facility.
• Ensure secure and compliant storage of pharmaceutical products.
• Monitor controls relating to medicines handling, distribution and record keeping.
• Ensure appropriate control measures are implemented for scheduled substances.
• Maintain compliance with applicable medicines control requirements.
• Oversee relevant pharmaceutical storage and distribution practices.
• Ensure accurate and compliant medicines records are maintained.
• Monitor medicines control risks and address identified compliance concerns.
• Ensure appropriate controls relating to pharmaceutical disposal requirements.

Batch Disposition, Product Release & Rejection

• Provide pharmaceutical oversight of batch disposition and product quality decisions.
• Review and approve batch disposition decisions where appropriately delegated and authorised.
• Ensure products released for distribution comply with approved specifications and applicable regulatory requirements.
• Evaluate product quality, safety and compliance considerations.
• Withhold or reject products where quality, patient safety or regulatory concerns exist.
• Ensure appropriate pharmaceutical judgement is applied to product release decisions.
• Collaborate with Quality Assurance and Quality Control teams on relevant product quality matters.
• Maintain appropriate documentation and traceability of authorised pharmaceutical decisions.

Pharmaceutical Quality Management Systems

• Maintain oversight of pharmaceutical quality systems.
• Ensure appropriate application of GMP and GPP requirements.
• Review significant quality deviations and compliance concerns.
• Oversee relevant Corrective and Preventive Action CAPA processes.
• Review significant change control activities.
• Support pharmaceutical quality risk management.
• Monitor the effectiveness of quality controls and corrective actions.
• Ensure significant quality issues are appropriately investigated and escalated.
• Support continuous improvement in pharmaceutical quality and compliance.
• Maintain awareness of product quality reviews and relevant quality management activities.

GMP Oversight & Manufacturing Compliance

• Provide pharmaceutical oversight of manufacturing, packaging, warehousing and distribution activities.
• Ensure pharmaceutical operations comply with applicable GMP requirements.
• Monitor manufacturing and operational practices that may affect product quality.
• Support compliance with applicable PIC/S GMP requirements.
• Review significant manufacturing-related quality risks.
• Ensure appropriate oversight of validation and qualification principles.
• Monitor compliance with data integrity requirements.
• Support appropriate controls relating to equipment, facilities and material handling.
• Identify and escalate significant GMP compliance concerns.
• Collaborate with operational and quality teams to address regulatory and quality risks.

Product Complaints, Quality Defects & Recalls

• Ensure pharmaceutical product complaints are appropriately investigated.
• Maintain oversight of significant product quality defects.
• Support product recall decision-making and recall governance.
• Ensure appropriate escalation of patient safety concerns.
• Monitor trends relating to product complaints and quality defects.
• Ensure applicable regulatory reporting obligations are fulfilled.
• Collaborate with relevant departments to support timely investigation and resolution of quality concerns.
• Promote appropriate risk-based decision-making in matters affecting product quality and patient safety.

Data Integrity & Regulatory Risk Management

• Maintain oversight of data integrity requirements within regulated pharmaceutical operations.
• Identify significant compliance and data integrity risks.
• Ensure relevant quality and regulatory records are accurate, complete and appropriately controlled.
• Monitor risks arising from pharmaceutical manufacturi