QA Operations Manager

Hobson Prior is seeking a QA Operations Manager to join a dynamic team in the biotechnology sector. This role, which offers a hybrid working environment, focuses on ensuring quality assurance and compliance within a GMP environment. You will lead the QA operations and Document Control team, manage internal audits, and act as the primary contact for operational issues.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Lead and guide the QA operations and Document Control team.
• Address operational issues and ensure smooth daily operations.
• Manage and execute the site's internal audit schedule.
• Approve and support investigations of significant quality events.
• Provide training and support for quality systems in various locations.
• Ensure resources are available to support a quality-focused culture.
• Review batch records promptly to facilitate timely batch release.
• Generate, review, and approve GMP documentation.
• Act as the main contact for external partners on quality matters.
• Ensure compliance with EU and FDA regulations.
• Serve as an expert for the Quality Management System during audits.
• Participate in preparing data for Quality Council.
• Conduct daily Tier 1 meetings for the QMS Team.

Key Skills & Requirements:

• Leadership and team development skills.
• Strategic thinking and risk management abilities.
• Experience in a sterile or aseptic GMP manufacturing environment.
• Understanding of controlled processes.
• Proficiency in Microsoft Office and eQMS systems.
• Strong planning and organizational skills.
• Excellent interpersonal skills.
• Ability to prioritize workload and work within agreed timescales.
• High attention to detail.
• Knowledge of GMP related to QMS activities.
• Ability to work both independently and as part of a team.
• Experience with regulatory inspections and audits.
• Ability to thrive in a fast-paced environment.

For more information, please contact Raif Valery.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.

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

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