Documentation Specialist (SN0731)
Job Description
We are seeking a Documentation Specialist to support and oversee batch manufacturing record (BMR) and cleaning validation protocol (CVP) documentation within a pharmaceutical production environment.
- The role involves coaching, reviewing, compiling, and ensuring compliance with GMP guidelines and ALCOA++ principles to maintain high-quality documentation standards.
Key Responsibilities
- Provide guidance and support to operators during production to ensure proper completion of BMR, CVP, and other documentation.
- Ensure compliance with ALCOA++ principles (attributable, legible, contemporaneous, original, accurate, complete, consistent, durable, accessible, and traceable).
- Collect, organize, and compile all relevant documentation for complete and compliant BMR/CVP records.
- Review documentation promptly after batch production to verify accuracy, completeness, and clarity.
- Identify and resolve missing or unclear information by providing feedback and seeking clarification from operators.
- Oversee and manage the BMR/CVP review process, ensuring timely and efficient execution.
- Regularly collaborate with stakeholders to discuss progress, developments, and the coordination of the review cycle.
- Continuously identify opportunities for improving documentation processes, including BMR/CVP preparation and review workflows.
- Train operators on proper documentation practices in alignment with GMP guidelines and ALCOA principles.
Education & Experience
- Vocational secondary education (MBO 4 level) or equivalent, preferably in a pharmaceutical setting.
- 2-4 years of experience as an operator or documentation specialist in a pharmaceutical or GMP-regulated environment.
- quality management systems
- Manufacturing Execution Systems (MES) and SAP
Required Skills
- GMP guidelines and ALCOA principles.
- High attention to accuracy and detail in documentation.
- Ability to work under tight deadlines and manage multiple priorities
- Process Improvement & Training
- Document Compilation & Review
- Coaching & Mentoring
- Issue Resolution & Coordination
Languages
- Dutch
- English
Hiring Team Member
