Deputy Manager / Manager-API DQA, R&D, Jeedimetla, Hyderabad Sigachi Industries

10.0 - 15.0 years

9 - 12 Lacs

hyderabad

Work from Office

Candidates who can join in One month are preferred Document Review: Review documents from R&D, AR&D, and other departments to ensure accuracy, completeness, and compliance with internal and regulatory standards. Process Change Evaluation: Assess and provide guidance on proposed process changes, ensuring they align with quality and compliance requirements. Quality by Design: Promote quality by design principles, ensuring process robustness and compliance throughout all stages of product development. Compliance & Audits: Ensure adherence to stage-gate processes, conduct internal audits, and support external inspections as required. Documentation Management: Maintain accurate and comprehensive documentation for laboratory and plant operations, including SOPs and procedural documents. Quality Reporting: Prepare expert in-house quality reports and contribute to Quality Overall Summaries (QOS) for regulatory submissions. Process Improvement: Identify opportunities for process and tool improvements to enhance efficiency, compliance, and quality. Risk Assessment: Facilitate risk assessments and actively monitor the implementation and effectiveness of mitigation plans. Training & Development: Coach and train cross-functional teams on quality best practices, fostering a culture of quality and continuous improvement. Regulatory Compliance: Ensure consistent compliance with applicable regulatory standards, including GMP, GLP, and GCP. Data Quality Assurance: Where applicable, ensure the integrity, accuracy, and reliability of datasets through data profiling, cleaning, and validation activities.

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