Deputy Manager / Manager - API DQA, R&D, Jeedimetla, Hyderabad , Sigachi Industries
Job description - 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 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 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.(ref : iimjobs.com)