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VQ Life Sciences are recruiting for a Permanent QC Validation Specialist based in North London.

As a QC Validation Specialist, you will be responsible for supporting the laboratory by providing specialist knowledge and problem-solving ability for all analytical techniques, problematic results, and validation requirements across the section and working as the subject matter lead.

Key duties and responsibilities include:

• Ensure that agreed section and project timelines are implemented and achieved.
• Train staff in validation activities, to enable the right level of support required to achieve workload.
• Identify, and validate new equipment within QC.
• Prepare and review validation life-cycle documentation.
• To adhere to ICH and regulatory guidelines for analytical method validation.
• Have a strong knowledge of validation requirements within a GMP environment to enable correct level of validation for specific regions and resolution of issues.
• Maintain familiarity with laboratory operating, quality assurance/quality control procedures, quality system regulations and standards in order to assist the Team leader and Quality Manager.
• Work cross-functionally with other departments or teams and attend meetings as required.
• To lead technology transfer and validation projects.
• To take responsibility for and deliver training and coaching to all members of the department.
• Ensure work is in line with regulatory requirements and guidelines.
• To ensure data trend reviews and analysis is performed.
• To take part and to lead continuous improvement initiatives.
• To participate with the receipt of audits from internal and external sources.
• To adhere to record and data integrity requirements.
• Provide specialist advice to the Team Leader and Quality Manager for problem solving and fault diagnosis.
• To be the subject matter experts in relation to the work of the section.
• Participate in continuous improvement projects across the section.
• To assist staff with the implementation of company policies, following cGMP guidelines.
• Preparation of technical documentation such as procedures, protocols and reports.
• To keep the Team Leader/Quality Manager aware of all important issues.
• Preparing documents and responses for regulatory submission

Experience and attributes to make you successful in the role:

• Significant experience in a laboratory environment, with a focus on Technical knowledge of Methods
• Significant equipment validation experience in a QC environment.
• Good knowledge/understanding of GMP/GLP and experience of writing protocols and reports.
• Experience of raising, completing, and investigating quality records.
• Project management experience.
• Knowledge of industry guidelines.
• Experience of writing protocols and reports
• BSc in relevant subject (or equivalent experience)

If you’re an experienced QC Validation Specialist and interested in this Permanent role based in North London, please get in touch with David Owen;

t: 01925596199

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