Job Description

Job Description

Position Summary:

The  Batch Manufacturing Reviewer plays a critical role in ensuring that manufacturing documentation complies with regulatory requirements, internal standards, and cGMP guidelines. This position is essential to maintaining the quality and integrity of pharmaceutical products, supporting batch disposition, and contributing to continuous quality improvement initiatives.

• Batch Record Review:
• Independently review batch records for accuracy, completeness, and compliance with  cGMP and  SOPs , ensuring documentation follows  Good Documentation Practices (GDP) .

• Regulatory Compliance:
• Verify all manufacturing documentation aligns with applicable  regulatory standards and  internal quality policies .

• Deviation Management:
• Identify discrepancies during batch review and ensure  deviations are properly documented, initiated, and closed in a timely manner.

• Documentation Management:
• Maintain, organize, and archive batch-related documents for easy retrieval. Set up and manage  electronic and physical data/documentation systems .

• Batch Disposition Support:
• Assist in the evaluation and final disposition of  intermediates and finished products , including supporting systems such as  LUMAC .

• Quality Improvement:
• Identify trends, gaps, and opportunities for  continuous improvement in manufacturing documentation and quality processes.

• Cross-functional Communication:
• Collaborate with internal teams and communicate externally, as needed, to resolve issues related to batch documentation or compliance.

• Strong Knowledge of cGMP & SOPs: Demonstrated understanding of  current Good Manufacturing Practices and operational SOPs in a regulated environment.

• High Attention to Detail: Ability to conduct thorough and accurate document reviews with a critical eye for errors or inconsistencies.

• Excellent Documentation Skills: Proficiency in  Good Documentation Practices (GDP)and structured documentation workflows.

• Problem-Solving Abilities: Capable of identifying and reporting exceptions and discrepancies and working proactively to resolve documentation-related issues.

• Effective Communication: Strong verbal and written communication skills to engage cross-functional teams and ensure alignment on quality standards.

• Data-Driven Mindset: Ability to interpret data, detect trends, and provide insights that contribute to process and documentation improvement.

• Technical Proficiency: Experience with  records/data management systems and familiarity with electronic documentation tools.
  

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