Quality Assurance Officer

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 www.mnarecruitment.com.

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

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