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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
1. Implement, communicate and maintain company’s quality systems, in compliance with Marken’s Global QMS requirements.
2. Interact with clients on Quality Assurance (QA)/ GxP related matters under management supervision.
3. Effectively interact with Marken Departments and stakeholders to maintain that all QA tasks are appropriately supported by QA.
4. Support on internal audits.
5. Support client audits and regulatory inspections, including the preparation of appropriate materials required within those audits when applicable.
6. 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.
7. 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.
8. Identify relevant GxP/ Quality related training needs and deliver training where required.
9. Ensuring that the Marken Quality System and GxP Program are implemented and maintained.
10. Ensuring the accuracy and quality of records and documents.
11. Participate actively in all the internal Quality and/ or designated meetings.
General
1. Perform activities assigned by QA Management.
2. Travel as reasonably requested by the Line Manager to the performance of duties.
3. Support your line manager, that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
4. Adhere to Good Manufacturing/ Distribution / Clinical Practices
5. Undertake any other reasonable duties at the request of the Line Manager
6. Adhere to company Policies at all times.
Employee Type:
UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.
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