JOB SUMMARY
Responsible Pharmacist is to ensure continued compliance of the technical aspects of the business.
The purpose is to ensure compliance with all the provisions of the Pharmacy Act, 53 of 1973, as amended and other legislation applicable to services which specially pertain to the scope of practice of a pharmacist, and the legislation applicable to the pharmacy, in this case of the Pharmaceutical company Distribution (Pty)
The purpose is to ensure compliance with all the provisions of the Act 101 of 1964 and compliance to SAHPRA warehousing & distribution guidelines, as the Responsible pharmacist, in the case of
Pharmaceutical company Distribution (Pty) The Responsible Pharmacist will ensure adherence to GMP, GWP & SOPs at all times. This position will also comply with reasonable and lawful instructions as given by Managers or other Senior Personnel , as required.
PRINCIPLE DUTIES
- Take corrective measures in respect of deficiencies with regards to inspection reports of SAHPRA or SAPC or in terms of the Medicines and Related Substances Act, 101 of 1965.
- Manage quality compliance on site by ensuring local SOPs remain relevant, effective and current.
- Oversee overall management of daily quality activities such as relating to warehousing & distribution & QMS systems, such as Self Inspections, training, etc.
- Be responsible for communication with relevant regulatory authorities.
- Provide pharmaceutical support in decision making processes.
- Ensure that the company has a current warehousing & distribution license with relevant regulatory authorities.
- Maintain the Site Master File.
- To be responsible to SAHPRA for any act performed by or on behalf of the company, including omissions in this regard.
- To be responsible to Council for any act performed by or on behalf of the company, including omissions in this regard.
- Establish policies and procedures for the employees of the wholesale pharmacy with regard to the acts performed and services provided in the wholesale pharmacy.
- Ensure the safe and effective storage and keeping of medicine.
- Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines.
- Ensure that contracts exist between the wholesaler (contract giver) and third party contractors (contract acceptor) stipulating where all the responsibilities in terms of GWP lie.
- Ensure that the following registrations, recordings and licences are current and in place:
- The registration of the Responsible Pharmacist with the Pharmacy Council in accordance with the provisions of Section 14 of the Pharmacy Act;
- The premises licence of the wholesale pharmacy issued by the Director-General, Department of Health, in accordance with the provisions of Section 22(1) of the Pharmacy Act;
- The recording of the premises licence of the wholesale pharmacy at the Pharmacy Council in accordance with Section 22(2) of the Pharmacy Act, read together with Regulation 8(5) of the “Regulations relating to Ownership and Licensing of Pharmacies”; and;
- The wholesale licence issued by the SAHPRA in accordance with Section 22C (1) (b) of the Medicines Act.
NATURE AND SCOPE
KNOWLEDGE REQUIRED
- B. Pharm degree
- Registered with the South African Pharmacy Council
- Good computer literacy
- Knowledge of cGxP regulations
EXPERIENCE REQUIRED
- Minimum 5 Years Distribution experience
- At least 2 Years Quality Assurance
- Thorough understanding of the South African Regulatory Environment.
SKILLS REQUIRED
- Strong Communication Skills
- Ethical principles and behaviour
- Ability to work in a team
- Extensive support
- Deadline driven
- Customer Focus
- Can work well under pressure
- Detail oriented
- Good analytical skills
