Posted on :
24 Feb, 2022
24 Feb, 2022
To assist the Quality Assurance department with the compilation and maintenance of all QA administrative tasks to ensure a timeous release of product to market and maintenance of the Quality Management System.
ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOW at a high level of functioning with minimal guidance
Job Title: Quality Assurance Officer
Location: Westlake, Western Cape, South Africa
Reference #: #QAofficer
Contract Type: Permanent
Salary: Market Related
•Contribute to the creation and implementation of best practice processes and procedures to aid and improve operational performance and timeous release of product to market
•Contribute to timeous implementation of QA projects.
•Assist with OTC dispensing in line with business requirements
•Perform the the compilation and population of lot release packs in line with release priorities
•Assist with the release of printed packaging components and ensure all colour standards are signed off, filed and where necessary delivered to relevant suppliers or printers.
•Ensure the timeous coordination of the destruction process.
•Assist with the capturing of data and the maintenance of QA registers and send out reports as and when required
•Assist with the compilation and/or closure of CCP’s and Issue Logs
•Liaise with stakeholders as and when required
•Assist with policy passport uploads and the circulation of standard operating procedures and training material within the department.
•Facilitate the PQR process by compiling the various attachments for annual product quality reviews.
•Capture PTC chart entries and assist with the verification of PTC charts as and when required
•Assist with the management of reference standards and columns for existing products and new launches.
•Coordinate and/or obtain quotes for consumables as/when required
•Ensure all invoices received from laboratories are checked against approved pricelists and processed for approval
•Assist with the compilation of monthly QA reports to HOD
•Assist with sending out the weekly reports for CCP’s and policy passport statuses as and when required
•Assist with the coordination of technical and/or other agreements for signature
•Provide the necessary QA information to Compliance and Regulatory Affairs as and when required
•Assist with launch activities in line with business priorities
•Assist with compilation of minutes and actions as and when required
•To carry out any other administrative duty as and when required
•Assist with tracking, communication, and support of annual plan activities, including but not limited to annual stability plan, Product quality review schedule, Quality Agreement schedule, audits and risk management.
•Coordinate sample handling including receipt, storage and any sample sending requirements.
•Assist with Data Logger handling, temperature monitoring and OOS investigation activities.
•Assist with minor investigations ie sampling or quantity discrepancies.
•Compile, review and file stability reports
Good Manufacturing practice (GMP):
•Maintain all GMP principles in line with departmental Quality System and SAHPRA requirements
Documentation & Systems Management:
•Assists with SOP tracking, compilation and circulation for sign off.
•Assist with filing of QA documentation
•Assists with monthly status reports
•Drive accuracy and efficiency of the departmental eDMS
•Ensure ongoing compliance with GmP requirements
•Post Basic Pharmacist Assistant or Bachelor of Science
•Minimum 3 years working experience in an Quality Assurance administrative/coordination/officercapacity
•Knowledge of the quality environment within the pharmaceutical industry
Application Deadline: 11/03/2022