
Senior Supply Operations Quality Professional
3 days ago
As a senior associate in supply operations quality, you will play a vital role in implementing and maintaining quality management systems.
Main Responsibilities:- You will support the implementation of the Quality Management System (QMS) to ensure compliance with regulatory expectations.
- You will work closely with local stakeholders to implement and maintain quality standards and systems for product supply operations.
- You will assist with the timely implementation of applicable quality management systems and standard operating procedures within the organization.
- You will collect key quality performance indicators, evaluate trends, and identify actions to improve the QMS.
- You will monitor Key Performance Indicators (KPIs) of the QMS, evaluate significant trends, and identify actions.
- You will lead and/or participate in quality review meetings as required.
- You will provide support in preparing and coordinating health authority inspections and internal audits of Good Manufacturing Practice (GMP)/Good Distribution Practice (GDP) activities.
- You will perform the local release process of products under the distribution license.
- You will support the coordination of product repackaging and/or relabeling activities.
- You will review and approve documentation related to product repackaging and/or relabeling.
- You will intake and triage complaints, issue correspondence letters as required, and act as a contact point for regulatory agency reporters.
- You will lead and/or participate in deviation investigations using appropriate tools and work with cross-functional teams to implement corrective actions.
- You will notify management of significant concerns or deviations that have the potential to impact product.
- You will facilitate the development and execution of objectives and projects consistent with the business purpose.
- You will develop and maintain a quality culture within the team and organization.
- A minimum tertiary education in science, pharmacy, or a related discipline is required.
- A minimum of 5 years' experience in the pharmaceutical industry in a quality role is required.
- Fluency in English, written and verbal, is essential.
- Experience in quality administered systems and electronic documentation control systems is advantageous.
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