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Documentation Officer - Biosimilar

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  • الفئات: الهندسة
  • االقطاعات:
  • نوع الوظية:
  • المستوى الدراسي:
  • سنوات الخبرة: 3 À 5 Ans, 1 À 2 Ans
  • المنطقة: الجزائر
  • وضع في: 01-06-2026 à 10:59:39
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الوصف
Job Scope:The Documentation Officer is responsible for managing, controlling, and maintaining all production-related documentation to ensure compliance with company procedures, quality standards, and regulatory requirements.Job Requirements:Education: Engineer's or master’s degree in biology, Chemical Engineering, Process Engineering or a related field.Experience: Minimum of 2 years of professional experience in a similar position, ideally in the pharmaceutical industry.Professional Knowledge: - Good knowledge of GMP requirements and ISO 9001 Standards.- Proficiency in Office Software.- Ability to write technical and documentation documents.- Strong organizational skills and ability to work effectively in a team.- Results-oriented and committed to continuous improvement.- Good written and oral communication skills in French and English.Duties and Responsibilities:- Define, write, and update the Production Department's documentation system, including Standard Operating Procedures (SOPs) and technical documents in accordance with GMP requirements and internal procedures.- Participate in the standardization of practices and the improvement of technical documentation.- Develop, follow-up and analyse the Production Department's Key Performance Indicators (KPIs).- Participate in continuous improvement and operational excellence projects.- Contribute to the investigations and root cause analysis, as well as the implementation of Corrective and Preventive Actions (CAPA) and all QMS Production related documents.- Ensure compliance with HSE rules, industrial safety standards, and applicable pharmaceutical regulations.- Collaborate with various departments to establish and monitor the production activity schedule.- Participate in internal audits, regulatory inspections, and periodic department meetings.- Ensure the follow-up of the Production staff training plan and training files in accordance with the Training / Compliance department.
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