Responsible Pharmacist Gauteng

BRIEF DESCRIPTION:-

The Lead Pharmacist role at a pharmaceutical manufacturing firm involves directing pharmaceutical operations, ensuring regulatory compliance, overseeing medicines control, and maintaining quality governance. The main responsibilities include managing regulatory interactions, supervising pharmaceutical staff, overseeing medicines and scheduled substance control, and ensuring compliance with Good Manufacturing Practice (GMP) and Good Pharmacy Practice (GPP) standards. Essential qualifications include a Bachelor of Pharmacy degree, current registration with the South African Pharmacy Council, and extensive experience in sterile or non-sterile pharmaceutical manufacturing.

Job Title: Lead Pharmacist

Company: Boardroom Appointments

Description

A prominent pharmaceutical manufacturing firm seeks a seasoned and professionally certified Lead Pharmacist to direct pharmaceutical operations, regulatory compliance, medicines control, and quality governance at its Clayville facility.

The ideal candidate will uphold the legal and professional responsibilities of the Lead Pharmacist, ensuring all pharmaceutical activities adhere to the Pharmacy Act, Medicines and Related Substances Act, South African Pharmacy Council (SAPC) guidelines, South African Health Products Regulatory Authority (SAHPRA) stipulations, and relevant Good Manufacturing Practice (GMP) and Good Pharmacy Practice (GPP) standards.

This position demands extensive experience in pharmaceutical manufacturing, extensive regulatory knowledge, and the capacity to provide independent oversight of activities that influence medicine safety, product quality, efficacy, and regulatory compliance. The successful individual must exhibit sound judgment, strong leadership skills, and the courage to challenge, halt, reject, or escalate activities that may compromise patient safety, product quality, medicines control, or regulatory compliance.

Responsibilities

Lead Pharmacist Governance & Regulatory Compliance

• Carry out all statutory and professional obligations tied to the Lead Pharmacist role. • Ensure the licensed pharmaceutical facility operates per applicable laws and regulatory requirements. • Uphold compliance with the Pharmacy Act and Medicines and Related Substances Act. • Ensure adherence to SAPC requirements and SAHPRA license conditions. • Maintain compliance with applicable GMP and GPP guidelines. • Provide independent pharmaceutical oversight of operations and activities affecting product quality and patient safety. • Ensure the establishment and maintenance of appropriate pharmaceutical governance controls. • Monitor compliance with regulatory obligations and license requirements. • Identify and escalate significant pharmaceutical, quality, and regulatory risks. • Exercise appropriate professional authority to challenge, halt, or reject non-compliant activities. • Ensure consistent fulfillment of statutory Lead Pharmacist obligations.

Regulatory Authority Engagement & Inspection Management

• Serve as the primary liaison with SAPC, SAHPRA, and other relevant regulatory authorities. • Manage regulatory interactions concerning pharmacy practice and pharmaceutical facility compliance. • Coordinate and support regulatory inspections. • Ensure the facility remains inspection-ready. • 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 involved in 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 authorized 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 authorized. • 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 judgment 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 authorized 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 manufacturing and quality activities. • Support appropriate escalation and management of significant regulatory risks. • Promote effective documentation and traceability of pharmaceutical decisions. • Ensure regulatory risks are considered in operational and quality-related decision-making.

Departmental Management & Resource Planning

• Manage departmental resources and budgets. • Ensure adequate resources are available to support pharmaceutical compliance responsibilities. • Monitor departmental performance against agreed objectives. • Maintain effective pharmaceutical oversight and compliance capabilities. • Ensure appropriate succession planning and deputy coverage for Lead Pharmacist responsibilities. • Support effective resource utilization and capacity planning. • Identify opportunities to improve departmental effectiveness. • Maintain accountability for relevant pharmaceutical governance and compliance activities.

Training, Competence & Compliance Culture

• Promote a strong culture of pharmaceutical compliance and ethical conduct. • Ensure pharmaceutical personnel receive appropriate training. • Support training relating to GMP, GPP, and regulatory requirements. • Promote awareness of data integrity principles. • Ensure relevant personnel understand their professional and compliance responsibilities. • Identify training and competency development requirements. • Encourage continuous improvement in pharmaceutical quality and compliance practices. • Support professional development and knowledge sharing. • Reinforce accountability for patient safety, product quality, and regulatory compliance.

Cross-Functional Governance & Stakeholder Management

• Participate in relevant site governance forums. • Provide pharmaceutical oversight and professional input into strategic and operational decisions. • Collaborate with Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, and Operations. • Support effective communication between pharmaceutical and operational stakeholders. • Provide guidance on regulatory and pharmaceutical compliance matters. • Contribute to risk-based decision-making across the organization. • Maintain professional relationships with internal and external stakeholders. • Communicate significant pharmaceutical and regulatory concerns clearly and timeously. • Perform other reasonable duties aligned with the scope of the role, professional qualifications, and level of responsibility.

Minimum Requirements

Qualifications & Professional Registration

• Bachelor of Pharmacy (BPharm) degree – essential. • Current registration as a Practising Pharmacist with the South African Pharmacy Council (SAPC) – essential. • Pharmaceutical Manufacturing Experience • Candidates must meet the applicable experience and technical knowledge requirements for the relevant pharmaceutical manufacturing environment.

Sterile Pharmaceutical Manufacturing

• More than 5 years of post-community-service experience in sterile pharmaceutical manufacturing. • In-depth working knowledge of Annex 1 of the PIC/S GMP Guide (PE 009-17).

Non-Sterile Pharmaceutical Manufacturing

• No less than 5 years of post-community-service experience in non-sterile pharmaceutical manufacturing. • In-depth working knowledge of Annex 9 of the PIC/S GMP Guide.

Regulatory & Professional Experience

• Strong knowledge of the Pharmacy Act and Medicines and Related Substances Act. • Comprehensive understanding of SAPC rules and professional requirements. • Knowledge of SAHPRA regulatory requirements and pharmaceutical license conditions. • Strong understanding of applicable GMP and GPP standards. • Knowledge of the statutory responsibilities and professional obligations of a Lead Pharmacist. • Experience with pharmaceutical quality management systems. • Understanding of pharmaceutical manufacturing, packaging, warehousing, and distribution processes. • Knowledge of medicines and scheduled substance control requirements. • Experience with regulatory compliance, quality risk management, and inspection readiness. • Understanding of batch disposition, product release, and rejection principles where appropriately authorized. • Strong leadership, communication, and stakeholder management capabilities.