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Title: Production Documentation Specialist
Location: Haarlem, NL
Earlier start possible
Temp to perm, permanent position for the right candidates possible after 6 months
Within the Parenterals department, specifically in Visual Inspection and Packaging (VISP), responsible for reviewing, completing, and compiling all necessary documentation to ensure a comprehensive and accurate Batch Manufacturing Record (BMR) or Packaging Batch Record (CVP). I provide guidance and coaching to operators on the correct completion of BMRs/PBRs, ensuring compliance with all relevant quality standards, including Good Manufacturing Practices (GMP) guidelines and ALCOA principles.
Responsibilities
Reviewing, completing, and compiling all necessary documentation for a complete Batch Manufacturing Record (BMR). Throughout the drug manufacturing process, a detailed record is maintained of all activities performed, measurements taken, and the exact time each step was completed. Upon completion of a batch, all relevant information (including room data, cleaning validation, etc.) must be added to the BMR. This ensures a complete record of all production activities. To guarantee completeness and address any outstanding issues, a Reviewer oversees this process. The Reviewer provides guidance and coaching during production, verifies missing information, and reviews the entire BMR/CVP before submitting it to Quality Assurance for final inspection.
The Reviewer is stationed in the production department but collaborates with other departments as needed (Parenterals, Quality Assurance, Visual Inspection and Packaging, Innovation & Investigation, and others).
Core Activities:
• Coaching and mentoring: Providing coaching and guidance to operators during the production process to ensure that they complete the BMR, CVP, and other documentation in accordance with the ALCOA++ principles (attributable, legible, contemporaneous, original, accurate, complete, consistent, durable, accessible, and traceable).
• Document compilation: Gathering and organizing all relevant documentation for a complete BMR/CVP.
• Review: Reviewing the BMR/CVP as soon as possible after batch production to ensure completeness, accuracy, and readability.
• Issue resolution: Taking action on missing or unclear information by providing feedback and asking questions to the operators involved.
• Coordination: Coordinating and overseeing the BMR/CVP review process.
• Stakeholder communication: Regularly meeting with stakeholders to discuss progress, development, and coordination of the BMR/CVP review cycle.
• Continuous improvement: Proposing improvements to the BMR/CVP, review process, and documentation completion.
• Training: Training operators on how to correctly complete the BMR/CVP and other documentation in accordance with GMP guidelines and ALCOA principles.
Job requirements
Education level
Requires the skills and knowledge typically acquired through a vocational secondary education (MBO 4 level), preferably in a pharmaceutical setting
Knowledge
• Knowledge of GMP guidelines and ALCOA principles
• Experience with quality management systems such as Trackwise
• Understanding of BMR/CVP usage in pharmaceutical processes
• 2-4 years of experience as an operator or documentation specialist in a pharmaceutical environment is preferred
• Experience with MES and SAP is an advantage
Skills
• Demonstrated ability to work with a high degree of accuracy
• Fluent in both Dutch and English, both written and spoken
• Effective communication skills
• Proven ability to work under tight deadlines
Attitude
• The ideal candidate is quality-oriented, self-motivated, and a team player.
• We are looking for a candidate who is quality-focused and able to work independently
