Sigachi Industries - Deputy Manager/Manager - API DQA

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 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.