Ac12055 Responsible Pharmacist - Midrand Market-Related

Alec Cameron & Associates Recruitment Solutions; Gauteng; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Responsible Pharmacist to ensure compliance with regulations and manage the Sterile Manufacturing unit. The role involves overseeing quality compliance, staff management, and stock control while ensuring adherence to national and international guidelines. Ideal candidates will have a B.Pharm degree and significant experience in the pharmaceutical sector, particularly in management roles.

Qualifications

• At least five years in the pharmaceutical industry.
• Two to three years at management level.

Responsibilities

• Ensure compliance with cGMP and SAHPRA requirements.
• Manage pharmacy business administration as per Pharmacy Act.
• Oversee stock control and final product release.

Skills

Regulatory Compliance

Quality Management

Staff Management

Education

B.Pharm Degree

Management training

Job description

Responsible Pharmacist

The Responsible Pharmacist is to ensure that all pharmaceutical and related activities undertaken and/or under consideration are in accordance with licenses, legislation, and corporate guidelines.

The suitable candidate will take full responsibility for all pharmaceutical actions in the Sterile Manufacturing unit, ensuring compliance with national and international cGMP guidelines, and will be based in Midrand, Gauteng.

Duties & Responsibilities

Regulatory and Licence Compliance

1. Liaise with SAPC for statutory compliance and ensure Good Manufacturing Practice (GMP) and Good Pharmacy Practice (GPP) in the Sterile Manufacturing Unit.
2. Manage pharmacy business administration as per Section 25 of the Pharmacy Act.
3. Ensure compliance with SAHPRA requirements regarding medicines and related substances, including registration, pharmacovigilance, and handling complaints.
4. Ensure GMP and GLP compliance from suppliers and contracted laboratories.
5. Verify registration of personnel providing pharmacy services with the South African Pharmacy Council.
6. Notify the Pharmacy Council of service terminations and address inspection deficiencies.
7. Secure necessary authorizations to communicate with the Council.
8. Control manufacturing and distribution in accordance with the Medicines Act.
9. Participate in pharmacy business decision-making processes.
10. Ensure all staff act within their scope of practice and report non-compliance.
11. Maintain continuous pharmacy registration and facilitate Continuing Professional Development (CPD).
12. Oversee procurement, storage, distribution, and disposal of medicinal products.
13. Coordinate training for pharmacy staff and assess customer compliance with regulations.
14. Maintain up-to-date reference books as stipulated by SAPC.

Quality Compliance

1. Review quarterly risk reports and oversee Quality Management System implementation.
2. Approve SOPs and manage product complaints and Product Quality Reviews (PQR).
3. Ensure quality agreements with suppliers and compliance of distributors and transporters.
4. Foster a culture of continuous training and proper documentation.

Sterile Product and Facility Compliance

1. Manage the Aseptic Services Unit for compliance with cGMP and SAHPRA requirements.
2. Maintain equipment and validate processes.
3. Research and ensure adherence to occupational health and safety standards.

Staff Management and Training

1. Coordinate staff training, assess competency, and implement disciplinary actions if necessary.
2. Ensure cGMP training compliance for all staff.

Budgets and General Responsibilities

1. Manage budgets and strive to meet financial and production targets.
2. Represent the company at professional associations.

Stock Control and Production

1. Oversee stock control, cycle counts, and annual stock takes.
2. Responsible for final product release and manufacturing efficiency improvements.

Desired Experience & Qualifications

• B.Pharm Degree
• Management training

Work Experience

• At least five years in the pharmaceutical industry.
• Two to three years at management level, leading quality and/or production teams.
• Experience managing projects within the pharmaceutical industry is advantageous.