Job Description

A leading pharmaceutical company has a vacancy for a Deputy Responsible Pharmacist.
Job Purpose:
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.
Key Responsibilities:

• 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 the company's 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 in the company 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 the purchase, sale, possession, storage, safe keeping and return of pharmaceutical products.
• Ensure that the following registrations, recordings and licence are current and in place:
• The registration of the Pharmacist with the Pharmacy Council in accordance with the provisions of Section 14 of the Pharmacy Act.
• The premises licence of the wholesale or distributor 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 license of the wholesale or distributor 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"
• Assisting the RP to ensure that contracts (Service Level Agreements/ Technical Agreements) exist between service providers and principles stipulating where all responsibilities lie.
• To ensure that all employees are conversant with the system laid down for use and following the SOPs
• That the specified quality is maintained during storage and transport.
• To ensure that all logs are completed by the distribution / warehousing facility e.g. temperature control, cleaning, maintenance etc.
• To ensure that disposal or destruction of medicines is correctly and regularly performed under proper control so as not to be a health hazard.
• To ensure that an adequate pest control program is in place at the distribution facility, using acceptable food grade bait, and to ensure that precautions are taken to ensure that product contamination does not occur.
• To ensure that self-inspection audits are performed and any deviations followed up.
• To ensure that goods on arrival at the distribution facility are placed in quarantine, sampled for retesting after importation, and retained in quarantine until formally released where applicable.
• To update batch status to the market according to correct procedure.
• To check all relevant documentation to formally release final packed product for distribution where applicable.
• To ensure GDP/GWP training is provided to all employees on an annual basis.

Requirements:

• Bachelor's degree in pharmacy (BPharm).
• Active member with SAPC.
• Computer Literacy in MS Office.
• 2-3 years' experience as Pharmacist/Deputy Pharmacist.
• Experience in a Pharmaceutical distribution/wholesale environment would be an advantage.
• Experience using a Digital
• Quality Management Systems would be an advantage.
• Oracle R12 experience would be an advantage.

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com
Should you receive no feedback within 7 days, please accept your application as unsuccessful.

Skills Required