Quality Assurance Officer II

Proclinical is seeking a dedicated QA Officer II to join a dedicated team. This role will be in charge of batch reviews to ensure the timely release of drug products for clinical and commercial use. The successful candidate will also ensure compliance with quality and regulatory requirements for manufacturing and testing and oversee quality systems at approved vendors and suppliers.

Responsibilities:

• Manage the batch review program to ensure timely release of drug products, including Qualified Person release for the EU.
• Maintain and manage internal and external audit programs, leading audits of GMP materials and service providers.
• Oversee QA review of change controls and deviations related to Operations.
• Assist in establishing, implementing, and maintaining Quality Management Systems (QMS) in line with FDA, MHRA, and other regulatory standards.
• Interface with internal teams in Product Development and Quality Control Labs, and external vendors to support compliance with quality standards.
• Oversee QA interactions with external vendors such as Contract Manufacturing Organizations to ensure compliance with GXP quality standards.
• Support the oversight of compliance and Quality systems, including audits, vendor qualification, change control, deviation and investigation management, and corrective and preventive action systems.
• Support Clinical QA activities.
• Draft, review, and approve controlled documents, including standard operating procedures, validation documents, and material specifications.
• Perform other duties as assigned.

Key Skills and Requirements:

• Degree in a scientific or technical field.
• Previous working history in Quality Systems, technology, and/or supervision in a regulated biotechnology or pharmaceutical environment.
• GXP experience, including auditing.
• Knowledge of FDA and MHRA guidelines regarding GMPs.
• Excellent verbal and written communication skills.

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.