Responsible Pharmacist

Biogenetics Labs; Alberton; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A leading pharmaceutical company in South Africa seeks a Responsible Pharmacist to ensure compliance with regulatory standards while supporting a GMP-licensed cannabis manufacturing environment. The role involves supervising daily operations, handling product recalls and quality management, and ensuring the safety of medicines. Candidates must have a B.Pharm degree and be registered with the South African Pharmacy Council, with proven experience in GMP practices and regulatory audits. This position requires flexibility for shift work and adherence to all pharmacy regulations.

Qualifications

• Registered Pharmacist with the South African Pharmacy Council.
• Experience in GMP-regulated environments.
• Hands-on knowledge of Good Distribution Practice.

Responsibilities

• Supervise facility compliance to Pharmacy Act.
• Ensure patient safety and product quality.
• Manage recall procedures and product complaints.

Skills

GMP compliance

Regulatory knowledge

Pharmaceutical standards

Contamination control

Education

B.Pharm degree

Registered Pharmacist with SAPC

Professional indemnity insurance

Job description

This role offers a unique opportunity to join a world-class facility and contribute to the establishment and development of systems at the outset of an exciting new phase.

Job Description and Position in Company

A natural person who is a pharmacist and who shall be responsible to the Council for complying with all the provisions of the Pharmacy Act, Act 53 of 1973, and other legislation applicable to services which specially pertain to the scope of practice of a pharmacist, and the legislation applicable to the pharmacy which is under his or her personal supervision and who is registered as such in terms of the Act.

Purpose of Position

The Responsible Pharmacist (RP) position is a critical role in the company, ensuring compliance with regulatory requirements alongside the Quality Manager and Production Manager, maintaining patient safety, and overseeing operations.

The Responsible Pharmacist will ensure full regulatory compliance within a GMP-licensed medical cannabis manufacturing and distribution environment, supporting inspection readiness, product quality, and patient safety in alignment with SAHPRA, SAPC, GMP, and Medicines Act requirements.

Responsibilities

• To continuously supervise the facility in which he or she has been appointed.
• Compile a letter of delegation of authority in her/his absence.
• Have the appropriate qualifications and experience in the services being rendered by the facility.
• Ensure that persons employed in the facility who provide services forming part of the scope of pharmacy practice are appropriately registered with the Pharmacy Council.
• Notify the Pharmacy Council immediately upon receiving knowledge that his/her services as Responsible Pharmacist have been or will be terminated.
• Ensure that unauthorized persons do not obtain access to medicines or scheduled substances or the facility premises outside of normal trading hours.
• Establish policies and procedures for employees with regard to acts performed and services provided in the facility.
• Ensure the safe and effective storage and keeping of medicines or scheduled substances under his or her direct personal supervision.
• Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping, and return of medicines or scheduled substances.
• Initiate and co-ordinate all recall activities in conjunction with the Quality Manager.
• Control the manufacturing and/or distribution of medicines, scheduled substances, or medical devices in terms of the Medicines Act, 1965.
• Supervise every pharmacist appointed by the owner of the business.
• Ensure that the pharmacy owner complies with all conditions of ownership and business registration.
• Ensure that no person is appointed to perform any act falling outside the scope of practice of their registration category.
• Report, in writing, any non-compliance with the Pharmacy Act to management and furnish the Pharmacy Council with a copy thereof.
• Not introduce or carry out any instruction or order of management that could contravene applicable legislation.
• Be responsible to SAHPRA for compliance with the Medicines and Related Substances Act, 1965 (Act 101 of 1965) relating to manufacturing, storage, control, and distribution of medicines or scheduled substances.

Company-Specific Requirements

Product Complaints and Recall

• Ensure all product complaints are investigated, documented, and addressed appropriately.
• Ensure adverse drug reactions are acted upon and followed up without delay.
• Maintain complaint records and ensure procedural compliance.
• Manage medicine recalls or withdrawals according to approved procedures.
• Ensure full batch traceability for all distributed products.
• Take final recall decisions in consultation with the Quality Manager and SAHPRA.
• Ensure SAHPRA is immediately notified of any market withdrawal.

Returned / Rejected Goods

• Ensure returned goods are handled correctly, reasons determined, and actions recorded.
• Ensure rejected goods are managed according to approved procedures.
• Make final decisions, with the Quality Manager, regarding re-analysis, reprocessing, repackaging, or destruction.

Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)

• Ensure, together with the Quality Manager, that all employees are trained on the Quality Management System (QMS).
• Ensure compliance with GMP and GDP requirements across manufacturing, storage, and distribution activities.
• Facilitate and actively participate in SAHPRA regulatory inspections and audits, including preparation, execution, and CAPA responses.
• Ensure inspection audits are conducted on all third-party contractors and vendors.
• Verify that manufacturing operations comply with approved GMP procedures.
• Ensure product quality is maintained during storage and transport in line with GDP.
• Ensure adequate facilities and written systems are in place for contract manufacturers and packers.
• Ensure completion of all GMP logbooks and verification activities (environmental monitoring, cleaning, maintenance, etc.).
• Ensure medicines and hazardous substances are destroyed or disposed of under controlled and compliant conditions.
• Ensure adequate pest control programmes are in place and do not pose contamination risks.
• Ensure self-inspection audits are performed and all deviations and CAPAs are followed up.
• Ensure goods are quarantined on receipt, sampled where applicable, and formally released.
• Release batches to market according to approved procedures.
• Review and approve documentation prior to final product release.
• Ensure ongoing GMP and GDP training for all employees.

Classified Areas and Cleanroom Compliance

• Ensure compliance with GMP requirements for classified manufacturing areas (Grade D and higher).
• Oversee environmental monitoring, contamination control, cleaning validation, and gowning practices.
• Ensure personnel operating in classified areas are trained and compliant with cleanroom requirements.

Operational Flexibility

• The Responsible Pharmacist must be willing and able to transition into shift work as operational requirements evolve.
• Availability to support manufacturing, quality, and release activities across extended or non-standard operating hours.
• Maintain continuous supervision and regulatory compliance within a shift-based operating model.

Reporting Line

The Responsible Pharmacist will report to the Director of cultivation & Compliance and the COO and act as a liaison between directors, key personnel, and operational staff.

Required Qualifications and Experience

• B.Pharm degree from an accredited university
• Registered Pharmacist with the South African Pharmacy Council (SAPC)
• Registered with the Pharmaceutical Society of South Africa (PSSA)
• Appropriate professional indemnity insurance

Additional Required Experience

• Proven experience in GMP-regulated pharmaceutical or manufacturing environments
• Hands-on experience working with Good Distribution Practice (GDP)
• Direct experience participating in SAHPRA inspections and regulatory audits, including CAPA management
• Experience working in classified cleanroom environments (Grade D and above)
• Practical knowledge of batch release, deviation management, change control, and contamination control