FTC QA Release & Deputy Responsible Pharmacist at Adcock Ingram

Key Job outputs:

• To ensure the release for sale of finished product to the market. This release should include a completion of a checklist, which will ensure that all important release criteria has been met
• To review Batch Manufacturing Records (BMR), Batch Packaging Records (BPR) and batch analytical records prior to batch release.
• To ensure adherence to all in-house quality standards and regulatory requirements.
• To perform internal audits as part of the audit team.
• To review and approve Quality Management System elements such as deviations, incidents reports, change controls and CAPA’s affecting batch release.
• Maintenance of the document and retention sample stores where applicable.
• Perform and support internal quality audits where applicable
• Co-ordinate and ensure compliance to stability requirements of all products.
• Co-ordinate and provide training on quality systems/cGMP when required
• Review and approve allocated QMS (Quality Management System- Deviations, Change Controls and CAPAs)
• Monitor the storage of documents on the soft and hard copy filing systems.
• Implement operational to SOP’s and processes, in compliance to applicable regulatory standards.
• Generate Certificate of Conformance for Third Party release where applicable.

Deputy Responsible Pharmacist:

• 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 Applicant 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 MCC and immediate actions to be taken to manage the situation. Attend MCC 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 MCC.
• 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 authorised 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 the Medicines Control Council 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.
• Finished product release.
• Batch document review and confirmation for compliance with specifications and procedures.
• Training of authored SOP’s and certain Quality Systems where applicable.
• Implementation of Quality standards as per regulatory requirements.
• Internal & external Quality Audits.
• Filing of released or rejected BMR/BPR documents.
• Assist with filing master documentation and separation of superseded documents from current documents.
• Management of allocated Quality Management Systems elements.
• Compliance to requirements of Medicines and Related substances Act 101 of 1965 and Pharmacy Act 53 of 1974

Requirements

•  B. Pharm Degree
•  Minimum 2 Years Production/QA Experience

Closing date:12 February 2026.