JOB RESPONSIBILITIES

- Existing License management and compliances for manufacturing and trading units w.r.t. CDSCO, State FDA and FSSAI

- Import and Registration document preparation for CDSCO

- Preparation and review of DMFs in CTD format for export markets

- Overseeing Quality assurance activities at API and formulation units and preparation of plant related documentation including SMF.

- Performing Clinical review of existing products and conducting Clinical trials

- Generating and reviewing PSUR reports

- Assisting the PMT team for Clinical and regulatory inputs for products w.r.t marketing content, labelling etc.

- Maintenance and review of IPR approvals.

- Import and Export Clearance documentation preparation.

- Coordination with other departments for the smooth functioning of processes.

- Handling a team onsite and offsite.

- To perform APQR and plant audits.

- Any other duty assigned from time to time

QUALIFICATIONS:

1. Post Graduate in Lifesciences/Pharmacy/Medicinal Chemistry.

2. 5-6 years of experience in relevant field. Additional QA experience is preferred.

send your CV to office@prgpharma.com