Documentation Specialist

5 dagen geleden

Haarlem, Noord-Holland, Nederland Teva Pharmaceuticals Voltijd

The Opportunity

Teva Pharmaceuticals is seeking a meticulous Documentation Specialist to ensure the accuracy, completeness, and compliance of all documentation throughout the drug manufacturing process. This role is essential in maintaining the highest standards of compliance and quality in our production operations.

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 regulatory standards.
  • 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 regulatory principles, fostering a culture of accuracy and compliance.

Requirements

  • Knowledge of GMP guidelines and regulatory 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.

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