OneSource Specialty Pharma (Formerly Stelis Biopharma) is hiring for SME for QA team

OneSource Specialty Pharma (Formerly Stelis Biopharma) is hiring for SME for QA team.

1. Project Lead –

Qualification/Experience :
M.Sc / M. Pharm with 15 + years’ experience of which last 5 years in USFDA/EU Approved Injectable / Biologics Drug Substance Facility or Corporate Quality Role

JD :
1.To lead Quality Governance / Continuous Improvement Program at Site in coordination with cross functional teams.
2.Review Quality Metrics / Indicators and identification of improvement initiatives.
3.Drive implementation of Quality Improvement, IT, Automation and Efficiency improvement programs
4.Experience in IPQA and QMS activities in Injectable / Biologics DS Facility

1. QA (QMS / IPQA)
Qualification/ Experience :
M.Sc/M.Pharm with 8 to 12 years of experience.

JD:
1.To lead continuous improvement initiatives in Quality Systems across site.
2.Drive implementation of Quality Improvement, IT, Automation and Efficiency improvement programs.
3.Preparation, review and implementation of SOPs,, Protocols and Reports, QRMs, Trends, APQR, etc
4. Experience in Sterile Injectable / Drug Substance Manufacturing site
5.Experience in QMS role with sound understanding of Change Management, Deviation Management and CAPA systems

If interested, please share your resume to Nikhila.Pakalapati@arcolab.com.