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Quality Assurance Officer

1 week ago

Pretoria, Gauteng, South Africa MNA Recruitment Full time
Job Description:

A Quality Assurance Officer is required to ensure compliance with local regulations and quality directives in a global pharmaceutical company.

  • To oversee the overall management of Change Controls within the Group.
  • Collaborate with the Senior QA Manager on Training Plans rollout to all employees.
  • Assist with compiling Periodic Quality Reviews.
Main Duties and Responsibilities:
  • Responsible for supporting the preparation, review, processing, approval, and closure of change controls.
  • Scheduling change control meetings and gathering relevant information from internal stakeholders.
  • Documenting rationale for changes and identifying deliverables to implement changes in accordance with client procedures.
  • Driving timely implementation and closure of change controls while ensuring compliance with applicable quality standards and change control procedures.
  • Supporting the management of SOPs and training in eDMS and eLMS systems.
  • Assistance in the rollout and allocation of required training as per Role Plans and Profiles of each employee.
  • Supporting QMS to ensure compliance with SOPs and managing TrackWise systems (Deviations, CAPAs, Product Quality Complaints).
  • Initiation of Internal deviations, allocation of deviations, and ensuring timely closure of deviations.
  • Requesting local Periodic Quality Reviews from local Contract Manufacturing Organizations and assisting with report compilation.
  • Completing assigned Company training within specified timelines.
  • Forwarding received Product Quality Complaints, Adverse Events, and Medical Enquiries to relevant persons in Quality Assurance/Pharmacovigilance/Medical Affairs.
Qualifying Requirements:
  • Relevant Science Degree qualification.
  • Minimum 5 years relevant experience in the pharmaceutical industry (Quality Assurance, Production, and Quality Control).
  • Sound knowledge of GxP requirements and SAHPRA guidelines.
  • Embodying Values & Behaviours in all interactions.
  • Highly adapted interpersonal skills.
  • Problem-solving analysis skills.
  • Prioritizing tasks and demonstrating initiative.
  • Effective time management and deadline driving.
  • Ability to analyze complex data and seek relevant opinions.
  • Detail-oriented approach.
  • Ability to work under pressure.

Candidates meeting the criteria may submit their applications via this portal or the vacancy link on www.mnarecruitment.com.

Applicants are advised to expect feedback within 7 days. If no response is received, please consider your application unsuccessful.