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Documentation Specialist
2 maanden geleden
About the Role
Teva Pharmaceuticals is seeking a meticulous Documentation Specialist to ensure the accuracy, completeness, and compliance of all documentation throughout the drug manufacturing process.
Key Responsibilities
- Provide real-time guidance and support to operators during production, ensuring that they complete Batch Manufacturing Records (BMR) and Cleaning Validation Protocols (CVP) according to ALCOA++ principles.
- Gather and meticulously organize all necessary documentation related to each batch, ensuring a complete and traceable BMR/CVP.
- Conduct thorough reviews of BMRs and CVPs immediately after batch production to confirm accuracy, completeness, and adherence to regulatory standards.
- Identify and address any discrepancies, missing information, or unclear documentation by collaborating with operators and other stakeholders to rectify issues promptly.
- Oversee and coordinate the entire BMR/CVP review process, ensuring timely completion and submission of all records to Quality Assurance.
- Engage in regular meetings with stakeholders across various departments to discuss the progress and alignment of the BMR/CVP review cycle.
- Contribute to the ongoing enhancement of the BMR/CVP review process by proposing and implementing improvements that streamline documentation practices and increase compliance.
- Facilitate training sessions for operators on GMP guidelines and best practices for completing BMRs and CVPs in line with ALCOA principles, fostering a culture of accuracy and compliance.
Requirements
- Knowledge of GMP guidelines and ALCOA principles.
- Experience with quality management systems like Trackwise.
- Familiarity with BMR/CVP processes in pharmaceutical manufacturing.
- 2-4 years of experience as an operator or documentation specialist in a pharmaceutical setting preferred.
- Experience with MES and SAP is a plus.
