Quality Systems Officer

Proclinical is seeking a Quality Systems Officer to support GXP activities related to Quality Systems. The successful candidate will have a focus on improving Quality Systems to ensure compliance with current Good Manufacturing Practice and maintaining inspection readiness.

Responsibilities:

• Support day-to-day operations of the Quality System department across multiple sites.
• Lead and participate in continuous improvement initiatives.
• Review records and documents for completeness and regulatory compliance.
• Generate standard operating procedures and guidelines to enhance quality system functions.
• Manage document lifecycle within the Electronic Document Management System (EDMS).
• Track and trend compliance paperwork, including deviations and change controls.
• Oversee training documentation and compliance metrics using the learning management system (LMS).
• Assist with employee onboarding training on quality-specific procedural requirements.
• Regularly update organizational charts.
• Participate in the internal audit program.
• Create and modify user groups, training items, curricula, group trainings, and assignments.
• Conduct periodic reviews and audits of Quality Systems.
• Prepare Quality metrics.
• Manage the storage and archival of all controlled documents.
• Adhere to company documentation policies and maintain documentation systems.

Key Skills and Requirements:

• Practical experience in a regulated manufacturing environment or equivalent experience.
• Experience with validation of computerized systems and applicable regulations is preferred.
• Excellent verbal and written communication skills.
• Proficiency with Microsoft Office applications and EDMS.
• Ability to work in a dynamic environment with a clear sense of urgency.
• Strong organizational skills and attention to detail and accuracy.
• Ability to perform other related duties and ad hoc projects as required.

If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes at i.aymes@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.