Quality Assurance And Regulatory Affairs Job in Plasmagen Biosciences Pvt. Ltd
Quality Assurance And Regulatory Affairs
Plasmagen Biosciences Pvt. Ltd
4+ weeks ago
- Bengaluru, Bangalore Urban, Karnataka
- Not Disclosed
- Full-time
- Permanent
Job Summary
Design, implement and maintain the Quality Systems at R&D in conformance with Corporate policy and Statutory regulations. Monitor the process of the analytical lab for assurance of GLP practices. Review and authorize documents such as SOP, Process Information Note and Process Development Plan, Specification, STP, Qualification documents and Stability study protocols and reports. Review internal Quality Audit report and evaluate GLP compliance. Participation in audits & compliance activity. Review, evaluation and approval of Change control and Deviation. Review and approve quality agreement documents.
Responsible for activities related to dossier submission for test licence, NOC and other regulatory compliance. Handling of query raised by the regulatory bodies. Coordination with regulatory/Statutory bodies as and when required. ln addition to above, any responsibility assigned by HOD.
PlasmaGen Biosciences is looking for Professionals having 6 to 8 years of experience on quality assurance and regulatory affairs.
Role Description:
Quality Assurance
Regulatory Affairs
Experience Required :
6 to 8 Years
Vacancy :
1 Hire
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