Job
Description
Job purpose The ideal candidate will be responsible for compiling, managing, and maintaining critical documents and data related to batch records, assay records, and other essential documentation in a highly regulated environment. This role is crucial for ensuring the accurate tracking, trending, and compliance of data. Duties and responsibilities Compile Data from Batch Records: Collect and organize information from batch production records, ensuring all relevant data is accurately recorded and easily accessible. Ensure batch records are compliant with Good Manufacturing Practice (GMP) standards and relevant regulatory guidelines. Compile and Review Assay Records: Gather and manage assay data, ensuring it is consistently and accurately recorded. Collaborate with laboratory teams to ensure timely and correct documentation of assay results. Data Tracking and Trending: Monitor and track production and assay data over time to identify any variations, trends, or issues. Develop and maintain data tracking systems to ensure that trends and variations are documented, evaluated, and reported effectively. Prepare and present regular trend analysis reports to management and other stakeholders. Document Control: Maintain a system of organized, up-to-date documentation related to batch and assay records, ensuring compliance with all regulatory requirements. Review and approve documents for accuracy, completeness, and consistency in line with established protocols and SOPs (Standard Operating Procedures). Compliance & Quality Assurance: Ensure all documentation adheres to regulatory requirements such as FDA, EMA, ICH, and GMP guidelines. Participate in internal audits, inspections, and document reviews to ensure compliance with industry standards. Qualifications • Master degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, or related field. • 5+ years of experience in document management or quality control within the biopharma. • Strong knowledge of GMP, GLP (Good Laboratory Practice), and relevant industry regulations. • Experience in compiling and managing batch records, assay records, and production data. • Proficiency in Microsoft Office Suite and document management systems (e.g., Veeva Vault). • Excellent organizational skills with a keen attention to detail. • Ability to manage multiple priorities in a fast-paced environment. • Strong analytical skills and experience with data trending and report generation.
