Executive - DQA - R&D

Job Title: Executive / Sr. Executive Development Quality Assurance (DQA)
Department: Development Quality Assurance (DQA)
Educational Qualification: M.Sc. (Chemistry)
Experience: 4-6 Years
Job Location: R&D Center, Shadnagar

Job Responsibilities:

• Review process development reports and process-related documents, including Process Feasibility, Process Optimization, Lab Validation, and Technology Transfer.
• Ensure compliance with stage-gate quality requirements at different phases of product development.
• Coordinate with CRD and ARD to finalize specifications and ensure adherence to required standards.
• Prepare and review Standard Operating Procedures (SOPs), ensuring proper implementation and harmonization across departments.
• Review Quality Management System (QMS) documents, including Change Controls, Deviations, Incidents, and Errata from synthesis and analytical departments, ensuring timely closure.
• Manage the issuance of books and formats to all departments.
• Conduct internal audits for cross-functional departments to ensure compliance with Good Laboratory Practices (GLP).
• Review IT-related activities such as data backup and verification.
• Perform Quality Risk Assessment (QRA) and Quality by Design (QbD) as per requirements.
• Ensure adherence to cGMP, GLP, GDP, safety norms, and company policies.
• Oversee data archival, retrieval, and storage with a proper tracking system.

Key Skills Required:

• Strong knowledge of DQA processes in R&D.
• Familiarity with QMS, GLP, cGMP, and regulatory compliance.
• Experience in handling documentation, SOPs, and process validation.
• Excellent coordination and communication skills.
• Proficiency in internal auditing and risk assessment.