Quality Assurance Officer Gauteng

3 days ago


Pretoria, Gauteng, South Africa MNA Recruitment Full time

Reference: DBN003534-SS-1

A global pharmaceutical company has a vacancy for a Quality Assurance Officer.

Duties & Responsibilities

Job Purpose:

  • To ensure that the Group quality systems are in compliance with 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.

Main Duties and Responsibilities are:

  • Responsible for supporting the preparation, review, processing, approval and closure of change controls.
  • Responsible for scheduling change control meetings and working with the internal stakeholders to gather relevant information, specifications, master documents, validation/qualification materials, and other required data 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 with applicable quality standards and change control procedures.
  • Support with the management of SOPs 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 with SOPs and management of the TrackWise systems (Deviations, CAPAs, Product Quality Complaints).
  • Initiation of Internal deviations, allocation of deviations and ensure timely 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.

Qualifying Requirements are:

  • 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.

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

Should you receive no feedback within 7 days, please accept your application as unsuccessful.

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