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We are looking to recruit a permanent Responsible Pharmacist and the role will be based at the Cape Town Branch and will report to the Quality and Compliance Executive to ensure compliance with the medicines and related substances Act, Act 101 of 1965 and subsequently amended and the Pharmacy Act, Act 53 of 1974 and as subsequently amended.
Requirements:
B. Pharm. DegreeMin 3 Years’ experience in the Wholesale/ Distribution or Pharmaceutical manufacturing industry.Knowledge of GWP/GDP/GMPPharmaceutical Industry Laws and Regulations and Ethics.Current valid registration in good standing with SAPCStaff managementWriting skillExcellent computer skillsKnowledge of ISO standardsLegal Compliance
Duties:
To ensure compliance with Quality & regulatory standards and guidelines.To ensure that all licenses in respect of regulations are maintained for the branch.To maintain the Quality Management System (QMS) by preparing and updating SOP’s, conducting internal and external audits and monitoring staff training.To ensure effective management of product returns, product recall, destruction process and reporting of product complaints/ Adverse eventsTo ensure effective management of CAPAs & deviations and change controls calibration & maintenance of critical equipment.To ensure that product release and sampling are conducted within SLATo ensure that favorable audit reports are received from Distribution principals, to formulate replies to audits reports.To ensure management of the schedule 5 and 6 productsTo ensure that the validation plan is implemented and maintained.To ensure the availability of emergency after hours service.To ensure that there is continuous Pharmacist supervision of premises during operating hours.Responsible for all communication with SAHPRA and SAPC.
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8yMjAxNDg2NDU3P3NvdXJjZT1ndW10cmVl&jid=376097&xid=2201486457
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QUALIFICATIONS NEEDED:
Completed B Pharm Degree.Registered as a practising pharmacist with the SAPC.
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:
Experience in a production/manufacturing department.Prior learning experience to aseptic formulation and filling will be advantageous.
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:
Enforce safety regulations.Keep records of employees attendance and hours worked.Inspect materials, products, or equipment to detect defects or malfunctions.Read and analyze charts, work orders, production schedules, and other records and reports to determine production requirements and to evaluate current production estimates and outputs.Plan and establish work schedules, assignments, and production sequences to meet production goals.Performance manage staff.Establish and set KPIs and perform visual management of shift operations.Identify and action any quality defects by using quality management systems and root cause problem solving.Implementing continuous improvement actions to meet or exceed Company safety, quality, delivery, and cost objectives.Manage expenditure on shift including staff costs such as transport and overtime as well as consumption of consumables.Responsible for the timeous execution of all activities defined by the SA Pharmacy Act 53 of 1974 and its current amendments and the Medicines and Related Substances Control Act, No 101 of 1965 and its current amendments.Responsible for the timeous execution of all critical activities, predefined and agreed upon with the Responsible Pharmacist, Quality Assurance and Production departments.
This includes, but not limited to:
independently checking and signing each dispensed material and its mass or volumechecking and signing the addition of each material to the mixchecking and signing the identity of the bulk product and printed packaging materialchecking and signing that each packaging line or station is clear of previous product, packaging components records, or materials not required for the planned packaging operations, and that equipment is clean and suitable for use before any packaging is undertakenother critical activities or stages as defined within each department as agreed upon the Responsible Pharmacist and relevant Quality Assurance and Department Manager.the compounding, manipulation, preparation or packaging of any medicine or scheduled substance or the supervision thereof.the manufacturing of any medicine or scheduled substance or the supervision thereof.the purchasing, acquiring, importing, keeping, possessing, using, releasing, storage, packaging, repackaging, supplying, or selling of any medicine or scheduled substance or the sup...
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8yMDYxMDQ0NDE1P3NvdXJjZT1ndW10cmVl&jid=1368713&xid=2061044415
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