Quality Assurance Manager (M/F)

SB-PEPTIDE is a French company specializing in the synthesis, engineering, and analysis of peptides. With over 10 years of industrial experience and an international presence, our company supports players in the pharmaceutical, cosmetic, and agrochemical sectors. A human-sized SME of about twenty employees, we place quality, innovation, and customer satisfaction at the heart of our activity.

Job Description: We are looking for a Quality Assurance Manager to lead our Quality Management System (QMS), in compliance with Good Manufacturing Practices (GMP) and current regulatory requirements. A versatile position at the heart of a small structure where QA intervenes across the entire quality system, from procedural writing to the field.

Your Missions:

• Document System and QMS

Management and updating of the document system (procedures, operating modes, and registration forms) Verification of records and compliance with procedures in production Distribution and communication of quality documents internally

• Quality Event and Change Management

Management of deviations, non-conformities (CC), and CAPA, from opening to closure Management of "change control" Management of customer complaints and, if necessary, batch recalls

• Audits

Organization and follow-up of internal audits (GMP self-inspections) Preparation and management of client and authority audits (ANSM, etc.) Supplier/subcontractor audits

• Validation and Qualification

Qualification and monitoring of equipment Process validation Qualification of controlled atmosphere zones Coordination of equipment cleaning validation activities

• Quality Control

Support for the analytical validation of LCMS methods (assay, purity): validation of protocols and reports and management of release specifications Validation and review of OOS/OOT Monitoring of stability studies Support for the management of laboratory equipment

• Suppliers and Quality Purchasing

Qualification and quality monitoring of suppliers (raw materials, service providers)

• Regulatory Support

Contribution to the drafting of regulatory dossiers for submission to competent authorities Regulatory monitoring (GMP, ISO 9001)

• Training and Management

Management of the quality/GMP training plan for personnel Monitoring of quality indicators (KPI) and preparation of the management review

• Structuring Projects

Contribution to the implementation of a new production line in compliance with GMP Active participation in obtaining ISO 9001 certification, complementing and in consistency with the GMP framework, from a long-term development perspective

Profile Sought: Master's degree (Bac +5) in Pharmacy Quality Assurance Significant experience in a pharmaceutical environment required, ideally in production or quality control Good knowledge of GMP and associated regulatory requirements (batch records, regulatory filings) Knowledge of the ISO 9001 standard is a plus Mastery of documentary tools and procedure writing Rigor, autonomy, organizational skills Ability to intervene across the entire quality system, alone or in a small team Good interpersonal skills and ability to work in a team Good level of English (written, reading, spoken) Mastery of office tools (Excel, Word, quality software)

Why Join Us? A human-sized company with ambitious projects A modern and pleasant working environment Strong proximity between teams and short decision-making circuits The possibility to participate in structuring projects: new production line, certification

Benefits: RTT Daytime work </body>