QA Associate I - Marken

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Job Description

Main Purpose:

The Quality Assurance Associate I (QAA I) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies. The QAA I also needs to ensure compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Clinical Practices (GCP), Good Storage Practices (GSP), ISO 13485 and ISO 9001.

Main Duties And Responsibilities

• Implement, communicate and maintain company’s quality systems, in compliance with Marken’s Global QMS requirements.
• Interact with clients on Quality Assurance (QA)/ GxP related matters under management supervision.
• Effectively interact with Marken Departments and stakeholders to maintain that all QA tasks are appropriately supported by QA.
• Support on internal audits.
• Support client audits and regulatory inspections, including the preparation of appropriate materials required within those audits when applicable.
• Responsible for the QTA process, including ownership of the QTA from initiation of the QTA template through to final signatures and filing; assigning a QTA # and PRA # if applicable, and assuring compliance to the SOP, including ensuring a QTA is updated or retired appropriately.
• Collate issues, CAPA, Risk Assessment, Change Control and training metrics and identify quality improvement initiatives. Oversee activities that conclude on the appropriate close-out of all CAPA entries.
• Identify relevant GxP/ Quality related training needs and deliver training where required.
• Ensuring that the Marken Quality System and GxP Program are implemented and maintained.
• Ensuring the accuracy and quality of records and documents.
• Participate actively in all the internal Quality and/ or designated meetings.
  
  

General

• Perform activities assigned by QA Management.
• Travel as reasonably requested by the Line Manager to the performance of duties.
• Support your line manager, that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
• Adhere to Good Manufacturing/ Distribution / Clinical Practices
• Undertake any other reasonable duties at the request of the Line Manager
• Adhere to company Policies at all times.
  
  

Employee Type

Permanent

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