Job Detail

Research Associate - DQA

 Chennai, Tamil Nadu     3-6 Yrs    ₹4.5 - ₹08 Yearly

Role & responsibilities

• Responsible for ensuring that all pharmaceuticals products developed with the R&D Department meet the highest quality standards.
• Prepare and review regulatory dossier documents for DCGI, ROW and Export market business.
• Ensure all the documents meet regulatory requirements and guidelines including quality.
• Implement and maintain quality assurance systems and procedures for dosage preparation.
• Ensure compliance for Good Manufacturing Practices (GMP), Good Laboratories Practices (GLP) and other relevant regulatory standards.
• Collect, organize and review documents from F&D, ADL and other relevant departments.
• Prepare and review SOPs, BMRs, BPRs, PV Protocols/Reports, Stability Protocols etc. to ensure accuracy and compliance with manufacturing protocols.
• Manage quality documentation and records, including standards operating procedures (SOPs), Batch records and Test reports.
• Compile and review Product Development Reports (PDRs) to document the formulation and development process of products.
• Ensure all equipment is calibrated according to the schedule and the records are maintained.

Preferred candidate profile

Must have experience in OSD