Quality Assurance Officer

• To ensure that the Group quality systems are in compliance to local regulations and are aligned to Quality Directives:
• Responsible for the overall management of Change Controls within the Group,
• Assist Senior QA Manager with the rollout of Training Plans to all employees
• Assist with the compilation of Periodic Quality Reviews

• Responsible for supporting the preparation, review, processing, approval and closure of change controls.
• Responsible for scheduling change control meetings and working with the internal stake holders to gather relevant information, specification, master documents, validation/qualification materials, and other required data in order to effectively coordinate and manage the proposed change.
• Document the rationale for the change and identify deliverables required to implement the change in accordance with client procedures.
• Drive the timely implementation and closure of change controls while ensuring compliance to applicable quality standards and change control procedures.
• Support with the management of SOP’s and training in the eDMS and eLMS systems.
• Assistance in the rollout and allocation of the required training as per Role Plans and Profiles of each employee.
• Support to the QMS to ensure compliance to SOPs and management of the TrackWise systems (Deviations, CAPAs, Product Quality Complaints)
• Initiation of Internal deviations, allocation of deviations and ensure timeous closure of deviations.
• Requests local Periodic Quality Reviews from local Contract Manufacturing Organizations. Assist with the compilation of the reports thereof.
• The completion of all assigned Company training within the specified timelines
• Forwarding of all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs

• Qualification – Relevant Science Degree
• Minimum 5 years relevant experience in pharmaceutical industry (Quality Assurance, Production and Quality Control)
• Sound knowledge of the principles of GxP requirements and SAHPRA guidelines
• Embodies Values & Behaviours in all internal and external interactions.
• People skills – highly adapted interpersonal skills
• Problem solving analysis skills
• Priority setting – initiative and follow through
• Time management and deadline driver
• Ability to analyse complex data, seek relevant opinions
• Detail oriented
• Ability to work under pressure

MNA Recruitment