Responsible Pharmacist - Industry

Location: Midrand, Gauteng, South Africa
Date Posted: 09-11-2017
It is required that the holder of a manufacturer's licence should appoint a Responsible Pharmacist, to be named on the licence. 

The Responsible Pharmacist's duties are specific and are intended to ensure that every batch of medicinal product has been manufactured and/or packed and checked in accordance with legal requirements. 

A Responsible Pharmacist has a personal responsibility for ensuring that the required tests and controls are carried out and must sign or certify, for each batch, that the appropriate tests have been carried out and that it complies with the relevant product or certificate of registration.

REQUIREMENTS:
- Pharmacist
- registered with the South African Pharmacy Council 
Pharmaceutical industry experience ESSENTIAL

PRINCIPLE DUTIES
The Responsible Pharmacist must:
  • Ensure that he/she in fact continuously supervises the Company in which he/she has been appointed.
  • Have appropriate qualifications and experience in the services being rendered by such Company.
  • Ensure that persons employed in such Company and who provide services forming part of the scope of practice of a Deputy Responsible Pharmacist or Pharmacist are appropriately registered with Council.
  • Notify Council immediately upon receiving knowledge that his/her services as Responsible Pharmacist have been or will be terminated.
  • Take corrective measures in respect of deficiencies with regards to inspection reports of Council or in terms of the Medicines Act.
  • In Addition to the General Responsibilities also:
  • Ensure that unauthorised persons could not by lawful means obtain access to medicines or scheduled substances or the Company premises outside of normal trading hours.
  • Establish policies and procedures for the employees of the Company with regards to the acts performed and services provided in the Company.
  • Have a direct line of communication with and be part of Management.
  • Have access to all areas, sites, stores and records which relate to the activities being performed.
  • Regularly review and monitor all such areas, sites etc. or have delegated arrangements whereby he/she receives written reports that such actions have been carried out on his/her behalf.
  • Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or schedules substances.
  • Attainment of the quality objective by ensuring that there is a comprehensive designed and correctly implemented system of Quality Assurance by incorporating Good Manufacturing Practices, Good Warehouse Practices and Quality Control. The system should be fully documented and its effectiveness monitored. All parts of the Quality Assurance system should be adequately resourced with competent personnel and suitable and sufficient premises, equipment and facilities.
  • Ensure that each of the medicinal products to which the licence relates has been manufactured or packed and checked and that the following obligations have been complied with:
  • The principles of Good Manufacturing Practices have been followed;
  • The principles of processes have been validated;
  • All the necessary quality control checks have been performed, and account taken of the packing and packaging conditions including a review of batch records;
  • Any changes or deviations in packaging or quality control have been notified in accordance with a well-defined reporting system before any product batch is released;
  • Any additional sampling, inspection and checks have been carried out or initiated, as appropriate, to cover changes or deviations;
  • All necessary manufacturing, packaging and associated documentation has been completed and endorsed by suitable authorised personnel trained in the concept of Quality Assurance and Good Manufacturing Practices, and
  • To retain reference samples of each product batch at the site of manufacture for a period of time in compliance with guidelines.
  • Conduct and supervise training and development programs for personnel with the Company.
  • Ensure that the Company's health and safety requirements are met and adhered to by all personnel.
  • Maintains professional and technical knowledge by attending educational workshops and reviewing professional publications.

OTHER DUTIES
  • Legal
  • Complaints
  • Recall
  • Returned or Rejected Goods
  • Regulatory Requirements
  • Common Technical Document Product Registration
Kind regards / Groete
Erma
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ERMA DAVENPORT | Cell (+27) 082 882 3762  | F  (+27) 0866 000 516  | Skype Erma347_d |
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