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, 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 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 the 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 the vacancy link on
Should you receive no feedback within 7 days, please accept your application as unsuccessful.
#J-18808-Ljbffr
