Deputy Pharmacist

Overview

Ensuring compliance with all the provisions of the Act 101 of 1965;
Pharmacy Act, Act 53 of 1973 and all regulations and guidelines pertaining to the Wholesale license for medicinal products and Good Wholesaling/Distribution and Good Housekeeping Practices and Good Pharmacy Practice. Supervision of purchasing, acquiring, importing, keeping, possessing, using, releasing, storage, packaging, supplying or selling of any medicine or schedule substance or the supervision thereof.

• Compliance to national regulatory requirements (Act 101 of 1965; Pharmacy Act 53 of 1973, SAHPRA, PICS/WHO guidelines and OHS act) with respect to Quality Management Systems and current Good Distribution & Wholesaling Practices (cGDP/GWP).
• Establish an effective quality management system to support the Adcock Ingram Healthcare SAHPRA Licence.
• Ensure Standard Operating Procedures (SOP’s) are initiated, reviewed, approved and implemented
• Ensure that quality systems are implemented and comply with SAHPRA Guidelines.
• Review and approve Validation protocols and reports ensuring compliance with cGDP/GWP requirements.
• Maintain a satisfactory service level to Logistics Distribution.
• Lead quality review meetings with the involvement of the AIL RP and Managing Director to assess the effectiveness and applicability of the quality systems.
• Escalate non-compliance of the quality systems immediately to Executive Management where necessary and assist in addressing the non-compliance.
• Perform performance assessments of all direct reports against agreed objectives.
• Product Release (based on Applicant release)
• Audits (preparation and correcting any non-conformances found) and CAPA initiation and close-out
• Deviations and Non-conformance raising, monitoring and close-out. Raise, maintain and monitor deviations, non-conformances and CAPA’s.
• Supply and maintain S5 & S6 stock and Registers.
• Supply and maintain section 21 items.
• Assist with stock take.
• Dedicated storage area management (Damages, Quarantine, Returns, Cold Store & Schedule Stores).
• Management of reverse logistics (RETURNS).
• Pharmacovigilance reporting.
• Receipt, fine checking and sampling of 3rd party stock.
• Deputise the Responsible Pharmacist (RP) by performing all RP duties and accepting responsibility as stand in RP in the absence of the RP.
• Assisting the Responsible Pharmacist (RP) where required.
• Performing duties, tasks and reasonable instructions as delegated by the Responsible Pharmacist.
• Key holder to critical keys required for daily operations.
• After hours, call out in case of fridge failure or emergencies.
• Risk Assessments, initiate and lead Risk Assessment meetings with various personnel to understand occurrences and trends in quality, operations and distribution.
• Personal interaction in all critical regulatory interactions with SAHPRA; DOH and SAPC.
• Foster good working relationships with the health authorities, principals and internal customers.
• Participate in Marketing, Supply chain;
  Regulatory and Quality Assurance cross-functional teams.
• Inform all Pharmacists of Adcock Ingram Healthcare about current developments in the legislation and other developments regarding compliance with current Distribution Practices.
• Approve technical records and training.
• Ensure correct handling of recalled and quarantined stock.
• Ensure timely handling and reporting product complaints from within the warehouse or from external customers.
• Ensure continuous supervision of the wholesale or distributor pharmacy.
• Take corrective measures in respect of deficiencies noted regarding inspection reports of council or third-party audits conducted.
• In addition to the general responsibilities:
• Ensure that unauthorized people do not obtain access to pharmaceutical products in the wholesale or distributor pharmacy premises outside of normal trading hours.
• Establish policies and procedures for the employees of the wholesale and distributor pharmacy regarding the acts performed and services provided in the wholesale pharmacy
• Ensure the safe and effective storage and keeping of pharmaceutical products in the wholesale and distributor pharmacy under his/her direct personal supervision
• Ensure correct and effective record keeping of…