Responsible Pharmacist: Quality Assurance Manager

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.

Specific Tasks:

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

Assist the QA Manager(s) with management of the QMS, as required.

Job Qualifications

Bachelor degree Pharmacy (SAPHRA)

Qualified Pharmacist registered with SAPC

Junior candidate that completed Community Service (Opportunity to be trained and upskilled)

3-8 years QA or experience in manufacturing industry will be advantageous

Job Schedule
Full time

Job Number
R000097661

Job Segmentation
Experienced Professionals (Job Segmentation)