Permanent - Responsible Pharmacist - Ekurhuleni (East Rand) - South Africa

Reporting to Head: Group Regulatory Compliance

Job Purpose:

To fulfil the statutory and professional responsibilities of the Responsible Pharmacist as appointed by the Site Manager for the licensed pharmaceutical facility and to provide independent oversight of activities thereby safeguarding medicine safety, quality and efficacy, medicines control, licence compliance and regulatory compliance. The role is responsible for ensuring compliance with the Pharmacy Act, Medicines and Related Substances Act, SAPC requirements, SAHPRA requirements and applicable GMP & GPP standards, and for escalating significant regulatory and compliance risks through the appropriate governance structures.
The Responsible Pharmacist is accountable for ensuring that the licensed pharmaceutical facility operates in compliance with the Pharmacy Act, Medicines and Related Substances Act, SAPC requirements, SAHPRA licence conditions and applicable GMP & GPP requirements.
The Responsible Pharmacist is responsible for maintaining oversight of medicines and scheduled substance control, product release and rejection activities where appropriately delegated, licence compliance, supervision of pharmacists and personnel performing functions requiring pharmacist oversight, and the implementation of controls necessary to ensure the lawful and compliant operation of the pharmaceutical facility.
The Responsible Pharmacist serves as the primary liaison with SAPC, SAHPRA and other regulatory authorities on matters relating to pharmacy practice, licence compliance, medicines control, inspections, regulatory commitments and reportable events within the scope of the Responsible Pharmacist role.
The role has the authority to challenge, stop, reject or escalate activities that may adversely affect product quality, patient safety, medicines control or regulatory compliance

Key Job Outputs:

Medicines and Scheduled Substance Control.
•     Batch Disposition, Product Release and Rejection (where appropriately delegated).
•     Pharmaceutical Staff Supervision and Delegation.
•     Pharmaceutical Quality System Oversight, including deviations, CAPAs, change control and quality risk management.
•     Product Quality, Patient Safety and Regulatory Compliance.
•     Regulatory Authority Engagement and Inspection Management (SAPC, SAHPRA and other relevant authorities).
•     Product Complaints, Quality Defects, Recalls and Reportable Events.
•     GMP, Data Integrity and Regulatory Risk Oversight and Escalation.
•     Pharmaceutical Governance, Training and Compliance Culture.

Responsible Pharmacist Governance, Licence Compliance & Regulatory Authority Engagement
•     Maintain compliance with all licence conditions and regulatory requirements.
•     Act as primary company liaison with SAPC and SAHPRA.
•     Manage regulatory inspections and compliance commitments.
•     Ensure reportable events are communicated appropriately.
•     Escalate significant compliance and regulatory risks.
•     Ensure Responsible Pharmacist statutory obligations are fulfilled

Pharmaceutical Staff Supervision, Delegation & Medicines Control
•     Supervise pharmacists and pharmaceutical personnel.
•     Implement and maintain formal delegation systems.
•     Ensure compliance with pharmacist supervision requirements.
•     Ensure secure control of medicines and scheduled substances.
•     Ensure compliant storage, distribution and record keeping

GMP Oversight, Regulatory Risk Management & Inspection Support
•     Maintain oversight of GMP systems.
•     Monitor regulatory compliance risks.
•     Review significant deviations, CAPAs and change controls.
•     Support inspection readiness programmes.
•     Escalate significant quality and compliance risks

Resource, Budget & Departmental Management
•     Manage departmental resources and budget.
•     Maintain effective pharmaceutical compliance capability.
•     Ensure appropriate succession and deputy coverage for RP responsibilities.
•     Monitor departmental performance against objectives

Product Complaints, Recalls & Regulatory Reporting
•     Ensure complaints are appropriately investigated.
•     Support recall decision making and recall governance.
•     Ensure regulatory reporting obligations are fulfilled.
•     Monitor trends relating to quality defects and patient safety risks

Training, Competence & Compliance Culture
•     Promote a culture of compliance and ethical conduct.
•     Ensure pharmaceutical personnel are appropriately trained.
•     Support GMP, GPP and data integrity awareness programmes.
•     Drive continuous improvement in compliance culture

Cross Functional Governance & Stakeholder Management
•     Participate in site governance forums.
•     Provide pharmaceutical oversight in strategic decisions.
•     Collaborate with Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain and Operations.
•     Support effective risk-based decision making across the organisation

Adhoc
•     Perform any other duties as may reasonably be required from time to time, in line with the scope of the role, organisational requirements and the incumbent’s skills, qualifications and level of responsibility

B Pharm Degree

Registered as Practicing Pharmacist with South African Pharmacy Council

Sterile Pharmaceuticals:

More than 5 years post community service experience in sterile manufacturing of pharmaceutical products

Demonstrate and in-depth working knowledge of Annex 1 of PIC/S GMP Guide (PE 009-17)

Non-sterile Pharmaceuticals:

No less than 5 years post community service experience in manufacturing Pharmacy

Demonstrate an in-depth working knowledge of Annex 9 of the PIC/S GMP Guide

Compliance with the Pharmacy Act, Medicines and Related Substances Act, SAPC requirements, SAHPRA license conditions and applicable GMP/GPP requirements

Responsible Pharmacist governance, license compliance and pharmaceutical facility oversight

Regulatory Knowledge:
•     Pharmacy Act, Medicines and Related Substances Act, SAPC Rules and SAHPRA regulatory requirements applicable to the Responsible Pharmacist role.
•     SAHPRA licence conditions and requirements applicable to pharmaceutical manufacturing and distribution facilities.
•     PIC/S Good Manufacturing Practice (GMP) requirements and Good Pharmacy Practice (GPP) requirements, where applicable.
•     Responsible Pharmacist statutory duties, accountabilities and professional obligations.
•     Pharmaceutical Quality Management Systems (QMS), including deviations, CAPAs, change control, complaints, recalls, product quality reviews and quality risk management.
•     Regulatory inspection management, audit readiness and response to regulatory observations
•     Batch disposition, product release and rejection principles where appropriately delegated and authorised.
•     Medicines and scheduled substance control, storage, distribution, record keeping and disposal requirements.
•     Drug safety principles

Process Knowledge:
•     Pharmaceutical manufacturing, packaging, warehousing and distribution processes sufficient to provide effective Responsible Pharmacist oversight.
•     Validation, qualification and data integrity principles applicable to regulated pharmaceutical operations.
•     Packaging and material handling
•     Equipment and facility control

Core Competencies:

Capacity planning and utilization
o  MS Office Suite packages
o  Safety Health and Environment
o  Stakeholder Management
o  Regulatory authority engagement and communication with SAPC, SAHPRA and other relevant authorities.
o  Stakeholder management, communication, report writing and regulatory correspondence skills.
o  Analytical & Problem-Solving Skills
o  Leadership & Management Skills
o  Supervision of pharmacists and personnel performing functions requiring pharmacist oversight.
o  Detail oriented and works with a high degree of accuracy
o  Communication Skills