Team Member - DQA

Role: Team Member - DQA (Development QA) Experience: 5 to 10 years Qualification: Masters Must have skills: Must have Experience in Quality Assurance with API R&D / NCE CDMO labs facility. Previous stint in analytical development for NCE / API will be added advantage. To ensure Compliance with Corporate Policies (Quality, Safety, COBE etc.) To ensure respective Standard Operating Procedures to be followed during the development of the molecules. Preparation, review, approval, control and revision of standard operating procedures. Preparation, review, approval, control and revision of Site Mater File, Quality agreements. Documentation control (Issuance, Retrieval, Supersede, Obsolete and Destruction) Investigation, Implementation, Approval and Compliance of Quality Systems (Change Controls, Incidents, OOS and CAPA) Coordinate with the plant team to investigate complaints, stability OOS, and manufacturing incidents. Review and Approval of Calibration and Preventive Maintenance Schedule and to ensure the activity carried out as per the schedule Review and Approval of Qualification Protocols and Reports (Facility, Utility, Equipment,) Review of Experiments in Electronic Lab Notebook (ELN) Review, Approval and distribution of Analytical Method Validation protocols, Reports, Specification & Method of analysis, cleaning validations, Method summary reports etc., To perform Quality Risk Assessment and QbD as per Customer Requirement Supporting regulatory affairs team for ANDA/NDA filling and regulatory deficiency closure Planning and Execution of activities related to Development Quality Assurance. Qualification and Compliance of External Manufacturing Facilities (SBP). Participate in Customer Teleconferences and respond to the Customer queries. Review presentations and presenting quality issues through Quality Management Review. Review, approval, distribution of development documents like Feasibility report, Optimization report, Familiarization report, FMEA report, QBD report. Allot the project code for the new project, allot technical numbers & document numbers to AR&D and R&D. Conduct gate meeting and facilitate the technology transfer between development and absorption team. Handling of technology transfer queries and arranging technology transfer documents by coordinating with the concerned departments. Review of Master Batch Production records, change notifications received from SBP’s and approve, issue in timely manner. Tracking of customer audit reports and responses. Any other responsibilities assigned by the group leader/head of the department Interested candidates with relevant experience may share profiles to pranavgayal@aurigeneservices.com