Rivonia-Johannesburg
Job Description
General :
- Aid and support the Responsible Pharmacist to ensure compliance to:
- SAHPRA for compliance with the requirements of the Medicines and Related Substances Act 101 of 1965, and the
- Pharmacy Council for compliance with the requirements of the Pharmacy Act, 53 of 1974.
- Aid and support Health Safety & Environmental compliance.
Quality Data Capturing
Update and maintain the Quality Release Databases
Receipt of QA Release Samples from Reception capturing information from sample, delivery note, Temperature Logger into the database
Collate relevant Batch Documentation and capture information into databases
Follow up on any missing Batch Documentation
Developing and maintaining an accurate filing system for Batch Release Information
Aid with Product Recalls (including mock recalls) data collation and reporting
Operate as content and access administrator for internal website and SharePoint database, within the constraints for legislation
Track Inbound Planning Report(s) to proactively request Batch Documents
Track DC Receipt to ensure samples are sent to office as soon as possible
Quality Assurance Batch Release
Review Certificates of Analysis, Certificates of Conformance and relevant shipping records to perform the Final Batch Release of Finished Products in accordance with SAHPRA requirements to ensure the public received products that are safe, effective and of good quality.
Ensure that samples received from the manufacturer meet regulatory requirements and that retention samples for each batch manufactured, are retained at the Distribution 3PL for the regulated time frame.
Query and resolve any non-conformances on CoAs or batch documents with the contract manufacturers to facilitate batch release.
Document control and archiving in accordance with SAHPRA requirements.
Analysis and Reporting on Product Release statistics quarterly during Quality Management Review Council Meeting.
Perform due diligence on at least one Batch Manufacturing and Packaging Record for imported Finished Products per Pharmaceutical SKU on the Company Product List, in accordance with regulatory requirements.
Perform Annual Customer Verification to ensure that customer are aptly licensed to purchase medicines from the Company.
Preparation of QA Release Samples for safe product disposal
Document Management System
Assisting with the compilation, review and updating of QMS Documentation, including but not limited to local procedures, policies and supporting documents.
Developing and maintaining an accurate filing system.
Keeping filing up to date, and secure.
Maintaining a neat and well-organised documentation system.
Photocopying, scanning & binding of documentation
Customer Service
To provide and ensure a high level of service, to internal and external customers through
- Proper product knowledge
- Supplying correct information timeously
- Good communication with other departments
Job Qualifications
Bachelor degree Pharmacy (SAPHRA)
Qualified Pharmacist registered with SAPC
Junior candidate that completed Community Service (Opportunity to be trained and upskilled)
1-2 years QA or experience in manufacturing industry will be advantageous
Job Schedule
Full time
Job Number
R000097661
Job Segmentation
Experienced Professionals (Job Segmentation)
