Quality Assurance Officer - Johannesburg, South Africa - MNA Recruitment

MNA Recruitment

Verified Company

Johannesburg, South Africa

15 hours ago

Posted by:

Thabo Mthembu

beBee Recruiter

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

Job Purpose:

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

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 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

Requirements:

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