Job detail for Product batch release

Objective/Deliverable:

• Participate in Quality processes,
• Provide support for the Quality processes involved,
• Ensure a presence on the shop floor and actively participate in the resolution of QA malfunctions in your sector.

The main tasks are as follows:

• Drafting of risk analyses, protocols, and validation reports,
• Review of batch records,
• Drafting of batch abstracts for the various batches produced,
• Management of deviations related to the products concerned, drafting of significant deviation reports and complaints,
• Management of Change Controls related to the projects followed,
• Release of active ingredient and synthetic intermediate batches, receipt/release of raw materials,
• Participation in audits and inspections, BLA review, and responses to questions in the context of regulatory submissions,
• Communication and exchange of information with third parties,
• Drafting of annual product/utility/environment reviews,
• Registration of documentation shared with third parties (Manufacturing sheet, Deviation report, Change Control, Validation report, Product review, etc.),
• Management of associated actions in the ERP,
• Expertise in cleaning validation for products,
• Drafting of cleaning validation documentation: protocols and reports, monitoring of protocol execution, and management of anomalies,

Profile: Master's degree (Bac +5) in Quality or engineering profile with experience on an industrial site

Working/writing language(s): French and English (C1)

Soft skills and expertise:

• Knowledge of GMP, knowledge of Biotechnology Production and Laboratory appreciated
• Knowledge of ICH Quality regulations and international Quality guidelines
• Analytical and synthesis skills
• Strong rigor and methodology
• Team spirit
• Good writing skills
• Adaptability

Pursue progress, discover extraordinary

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The salary range for this position is: €48.000,00 - €64.000

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.