Quality Assurance Officer Market related - South Africa
Vela Personnel
Purpose: Ensure that group's quality systems are in compliance to local regulations and are aligned to the company's quality directives Key Job Outputs: Responsible for the overall management of the group change controls Assist senior QA manager with the rollout of training plans to all employees and with the compilation of periodic quality reviews Supporting the preparation, review, processing, approval and closure of change controls 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 company's QMS to ensure compliance to company 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 and 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 Core Competencies: Sound knowledge of the principles of GxP requirements and SAHPRA guidelines Embodies company 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 Qualifications: Relevant Science Degree Experience: Minimum 5 years relevant experience in pharmaceutical industry (Quality Assurance, Production and Quality Control) Salary: Market related Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful. All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013
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