Responsible Pharmacist 23 views

Job Overview

  • Salary Offer Market Related
  • Experience Level Junior
  • Total Years Experience 5-10

Purpose:

A Responsible Pharmacist ensuring compliance with all the provisions of the Act 101 of 1965; Pharmacy Act, 1974 (Act 53 of 1974) and all regulations and guidelines pertaining to the wholesale license for medicinal products and good wholesaling/distribution and (HPPP), 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 Job Outputs:

  • Ensure that persons employed in the Pharmacy and who provide services forming part of the scope of pharmacy practice of a pharmacist are appropriately registered with the South African Pharmacy Council
  • Notify the Pharmacy Council immediately upon receiving knowledge that your services as Responsible Pharmacist have been or will be terminated
  • Take corrective action in respect of deficiencies with regard to inspection reports of the pharmacy council or in terms of the medicines act
  • In addition to the general responsibilities also ensure that unauthorised persons do not obtain access to medicines or scheduled substances or the pharmacy premises outside of normal trading hours
  • Establish policies and procedures for the employees of the pharmacy with regard to the acts performed and services provided in the pharmacy
  • Ensure the safe and effective storage and keeping of medicines or scheduled substances in the pharmacy under your direct personal supervision
  • Ensure corrective and effective record keeping of the purchase, sale, possession, storage, safekeeping, and return of medicines and scheduled substances
  • Inform contract givers immediately of any (customer complaint, OOS) investigations that indicate the possibility of a recall
  • Prepare investigative reports and discuss with the applicant the process of notification to SAHPRA and immediate actions to be taken to manage the situation
  • Attend SAHPRA recall discussions and meetings with the applicant
  • Convene regular meetings with all department managers to discuss actions taken for the recall process
  • Manage the implementation and completion of CAPA proposed to the applicant and SAHPRA
  • Compile a letter of delegation of authority during periods of absence
  • Control the manufacturing or distribution of medicines, scheduled substances or medical devices in terms of the provisions of the medicines act, 1965
  • Ensure that there is compliance with good pharmacy practice as published by the pharmacy council
  • Supervise every pharmacist appointed by the owner of the pharmacy business
  • Ensure that the pharmacy complies with all the conditions of:
    •  Ownership of such pharmacy business
    • Registration of the pharmacy
  • Ensure that no person is appointed to perform any act falling outside of the scope of practice of the category in which such person is registered or which he/she is not authorized to perform in terms of the pharmacy act, 1974 (act 53 of 1974)
  • Report in writing any non-compliance with the pharmacy act to the management of such pharmacy business and furnish pharmacy council with a copy thereof
  • Not introduce or carry out and instruction or order with regard to the pharmacy business of the pharmacy owner which could amount to contravention of legislation applicable to such pharmacy business
  • Be responsible to SAHPRA for compliance with the provisions of the medicines and related substance act, 1965 (act 101 of 1965) relating to the sale, control of the manufacturing and distribution of medicines, schedule substances or medical devices
  • Initiate and co-ordinate all recall and withdrawal activities, which should involve the head of quality
  • Ensure compliance to the following obligations prior to release of a batch:
    • The QA release pharmacist is delegated to in writing to perform release activities
    • All prescribed requirements of the registration of the medicine and manufacturing license are met
    • The principles of cGMP have been followed
    • The principal manufacturing and testing processes have been validated
    • All necessary quality control checks and tests have been performed, and account taken of the manufacturing and packaging conditions including a review of batch records
    • Changes and deviations in manufacturing, packaging or quality control are notified in accordance with a well-defined reporting system before any product batch is released
    • Additional sampling, inspection, tests and checks are conducted or initiated as appropriate, to cover changes or deviations
    • All necessary manufacturing, packaging and associated documentation are completed and endorsed by suitably authorized staff trained in the concept of and good manufacturing practices
    • The release parameters on the COA provided by QA are all within specification and the COA is signed by the QC supervisor
    • All relevant factors are considered, including any not specifically associated with the output batch directly under review, (e.g., calibration and maintenance records, environmental monitoring)
    • The legal requirements regarding imported products are fully met, by ensuring testing is conducted to verify the requirements and other tests to assure quality of the products
    • To maintain a register (or equivalent) as a record of product batches certified by the release pharmacist on batch release
    • To retain reference samples of each product batch at the site of manufacture for a period of time in compliance with guidelines

Core Competencies:

  • Ability to analyse information
  • Accuracy & attention to detail
  • Able to work under pressure
  • Organisational awareness
  • Ability to plan and work independently
  • Customer focus /service orientated
  • Team effectiveness

Qualifications:

  • Degree in pharmacy
  • Registration with the SAPC as a pharmacist

Experience:

  • Minimum 5 – 8 years relevant experience within pharmaceutical manufacturing environment

 

Salary:   Market related

 

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013

 

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Contact Details

Address: 1 Maxwell Drive | Sunninghill | Johannesburg | South Africa

Email: info@velapersonnel.co.za

Contact Number: 011 802 0185

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