Quality Systems Specialist

Company:
A leading organization dedicated to advancing healthcare through innovative and quality-driven solutions. Their mission is to support the development and manufacturing of life-saving therapies, focusing on improving patient outcomes worldwide.

Job Description:
The Quality Systems Specialist plays a vital role in supporting the deployment and management of the company’s quality systems. This position involves ensuring compliance, facilitating cross-site collaboration, and maintaining high standards in quality assurance activities related to regulated pharmaceutical processes.

Responsibilities:
-Oversee the maintenance, training, and continuous improvement of core quality systems such as Change Control, Deviations, CAPA management, and Material Review Board processes.
-Support site and cross-site compliance with regulatory requirements and quality policies.
-Facilitate training sessions and act as a backup chair for the EU Change Control Review Board, Deviations, and Material Review Board.
-Assist in regulatory inspections and audits, ensuring proper documentation and adherence to cGMP standards.
-Manage the review and approval of changes, deviations, CAPA records, and related documentation.
-Track and report metrics to identify opportunities for process improvements and support management reviews.
-Support multidisciplinary teams in startup activities and process improvements.
-Maintain the company’s Quality Management System and ensure timely approval of documents.
-Act as a backup support for the Senior Manager of Quality Systems and contribute to ongoing quality initiatives.
-Perform other related duties as required to uphold quality standards.

Requirements:
-At least 5 years of GMP Quality Assurance experience in a pharmaceutical environment (Drug Substance or Drug Product).
-Strong knowledge of GMP regulations, ICHQ10 standards, and relevant pharmaceutical law.
-Hands-on experience with Change Control, CAPA, Deviations, Internal Audits, and Material Review Boards.
-Knowledge of aseptic manufacturing processes.
-Proficiency in MS Word, Excel, PowerPoint, Smartsheet, Power BI, Power Automate, and quality management systems.
-A bachelor’s degree in technical fields such as Chemistry, Microbiology, Engineering, or similar.
-Preferred: Certifications such as ASQ, Black Belt/Green Belt, and experience with ATMPs.

Other Information:
If you are interested and want to apply, please submit your application via the apply button below and contact me

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