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Sigachi Industries - Deputy Manager / Manager - API DQA

Sigachi Industries - Deputy Manager / Manager - API DQA

Sigachi Industries Private Ltd.,Hyderabad, India
25 days ago
Job description

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)

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    Api • Hyderabad, India

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