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The opportunity
We are looking for a meticulous Reviewer Production Documentation to join our team. In this role, you will ensure the accuracy, completeness, and compliance of all documentation throughout the drug manufacturing process. Stationed in the production department, you will work closely with operators and collaborate with various departments, including Parenterals, Quality Assurance, and Packaging. Your responsibilities will include guiding operators in proper documentation practices according to ALCOA++ principles, compiling and organizing relevant documents, reviewing BMRs/CVPs for completeness, and driving continuous improvements in the documentation process. This role is essential in maintaining the highest standards of compliance and quality in our production operations.
How you’ll spend your day
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.