Industrial Affairs Officer F/H CDD 12-18 mois

BTG-posted 3 months ago
Full-time • Entry Level
Paris, TX
251-500 employees
Chemical Manufacturing
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SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies. For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world's leading portfolio of antidotes. Today SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries. Our Purpose is supported by our 4 key values: We make patients our priority, We act with integrity and accountability, We work together as one team, We look for better ways forward. By expanding our reach through selective acquisitions and entering new markets, we're not just supplying medicine; we're improving the standard of care for more patients around the world.

  • Support the Development of Existing and New Products
  • Participate in the evaluation and selection of CMO/CDMO for technology transfers or new developments.
  • Collect and review validation data for processes and analytical methods, highlighting any out-of-specification results or abnormal trends.
  • Contribute to the development of stability protocols, process validation, and analytical method validation.
  • Manage and track the progress of validation activities (analytical and manufacturing processes) and stability studies, reporting any out-of-specification results or abnormal trends.
  • Review updates to batch documentation for existing commercial products and assess their impact on process robustness or product quality, highlighting any significant variations.
  • Generate change control requests for the introduction of new products and modifications to existing products.
  • Support problem-solving activities in coordination with other departments (Quality, Supply Chain, Regulatory, etc.).
  • Participate in investigations for out-of-specification results or abnormal trends.
  • Ensure liaison with raw material and component suppliers to support the supplier qualification program.
  • Liaise with contract development and manufacturing organizations (CDMO/CMO) to collect and review technical information for the qualification program.
  • Assist the Quality Assurance (QA) department in maintaining qualification status.
  • Ensure all documentation is generated in compliance with internal procedures, SOPs, and applicable quality and regulatory requirements.
  • Ensure that all main documentation issued by external partners is produced on time according to the established schedule.
  • Document activities according to the current project process.
  • Ensure regular reporting on project progress and any difficulties encountered.
  • Previous experience in a pharmaceutical production, development, quality, or related industry is preferred.
  • Familiarity with GxP systems concepts, relevant ICH guidelines, and pharmaceutical terms and acronyms.
  • Experience in writing validation protocols for processes, analytical methods, and stability studies, as well as tracking their progress and reviewing and presenting data according to quality and regulatory standards.
  • Ability to establish and maintain effective working relationships with colleagues and internal and external stakeholders.
  • Solution-oriented mindset with strong written and oral communication skills.
  • Ability to clearly and concisely report any issues to relevant stakeholders.
  • Ability to support statistical analyses and product data evaluation.
  • Ability to interact in English with CDMO/suppliers is essential.
  • Master's degree
  • Engineering degree or pharmaceutical focus
  • Fluent in English
  • 12-18 month fixed-term contract
  • Offices in Paris 8th, close to line 1 and RER A
  • Remote work possible 2 days a week
  • 10 RTT per year
  • Competitive salary and benefits
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