Research Associate - DQA Desirous Global Consulting
Desirous Global Consulting
Office Location
Full Time
Experience: 3 - 3 years required
Pay: INR 500000 - INR 1000000 /year
Type: Full Time
Location: Chennai
Skills: Regulatory Affairs, Quality Assurance, SOPs, Batch Records, Calibration, Good Manufacturing Practices GMP, Good Laboratories Practices GLP, Product Development Reports PDRs
About Desirous Global Consulting
Job Description
Pharmaceutical & Life Sciences Full-Time Job ID: DGC00489 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,