Hobson Prior is seeking a Quality Assurance Consultant for a contract role based in Belgium. The successful candidate will be responsible for developing, implementing, and managing quality assurance activities in a nonclinical and non-regulated research setting. This role requires a strong understanding of GLP compliance and nonclinical quality subject matter.

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

Key Responsibilities

• Develop and manage quality assurance activities according to regulatory requirements.
• Oversee preclinical analytical Quality Operations activities.
• Write, review, and approve written standards, including Master Production Records, Standard Operating Procedures, Specifications, Test Methods, and Change Control Documentation.
• Conduct Quality / Technical review of lab quality-related issues.
• Manage lab technical investigations (deviations, out of trend, out of specification) associated with clinical study testing.
• Establish strong interfaces with contract testing laboratories to address and resolve complex and routine activities.
• Provide in-depth technical advice to project teams regarding Phase I-IV sample analysis, analytical and assay development.
• Support submission of INDs and NDAs.
• Participate as QA representative on relevant operations team.
• Perform toxicology study protocol, amendment, report and data audits.
• Monitor and author Quality Assurance standard operating procedures (SOPs) as required.
• Evaluate vendors to assure compliance to the required regulations and project needs.
• Provide GLP training and advice to staff.

Requirements

• Degree in a science-related field or equivalent experience.
• Knowledge of GCLP, GLP, Part 11 regulations, FDA Guidances for Industry, EU regulations, and other standards.
• Ability to think strategically and maintain an attention to detail.
• Strong problem-solving/analytical skills.
• Knowledge of Microsoft Office® applications and spreadsheet programs such as Excel, Word, Power Point, and Microsoft Project.
• Excellent written and verbal communication skills, strong negotiation and decision-making skills, and attention to detail.
• Strong organizational skills, with the ability to handle multiple tasks.

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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