Dqa

Responsible for supporting the US-Development Quality Assurance team, for the Development activities at the North American based sites.
- Review of Development Documents and process for IND, NDA, and ANDA, including Analytical methods, PDR
- Implement the Development Quality System for Promius Pharmaceuticals. Develop, implement, track, review, approve elements of the Quality Management System, including, but not limited to SOPs, Change Control, Deviations, Incidents, CAPAs, Product Complaints.
- Interface with R&D and Project Management Team to conduct audits of US based CROs and contract development sites(CDSs); -Study, evaluate and approve the manufacturing and filing process of CROs; CDSs, conduct re-qualification audits for those CROs/CDSs based at US.
- Facilitate for Performing Risk assessment and monitoring of proposed mitigation plans -Implementation of QbD tools wherever feasible in Product development process
- Responsible for supporting the US-Development Quality Assurance team, for the Development activities at the North American based sites.
- Review of Development Documents and process for IND, NDA, and ANDA, including Analytical methods, PDR
- Implement the Development Quality System for Promius Pharmaceuticals. Develop, implement, track, review, approve elements of the Quality Management System, including, but not limited to SOPs, Change Control, Deviations, Incidents, CAPAs, Product Complaints. -Interface with R&D and Project Management Team to conduct audits of US based CROs

and contract development sites(CDSs); -Study, evaluate and approve the manufacturing and filing process of CROs; CDSs, conduct re-qualification audits for those CROs/CDSs based at US.
- Facilitate for Performing Risk assessment and monitoring of proposed mitigation plans -Implementation of QbD tools wherever feasible in Product development process

**Salary**: ₹35,000.00 - ₹38,000.00 per month

Schedule:

- Day shift

Ability to commute/relocate:

- Noida, Uttar Pradesh: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 6 years (preferred)