Stelis Biopharma is looking for SMEs for the below sub-functions in the Quality Services team

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Stelis Biopharma is looking for SMEs for the below sub-functions in the Quality Services team.

1. Project Lead- M.Sc /M Pharm qualified with 15+yrs of work experience USFDA/EU Approved Injectable Manufacturing Facility or Corporate Quality role. 

Job Description:
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. Monitor, prepare and present progress/metrics to Management Teams
Review and approval of SOPs, Protocols and Reports 
5. Experience in IPQA and QMS activities in Injectable Manufacturing Facility.
Experience in Biological manufacturing is desired. 


2. Team Leader for QA - QMS/ Investigation/ Tech Transfer: M.Sc /M Pharm qualified with 8- 12yrs of work experience.

Job Description:
1. Drive implementation of Quality Improvement, IT, Automation and Efficiency improvement programs.
2. Review of investigations of Manufacturing, Quality Control, Microbiology and Engineering systems.
3. Preparation, review and implementation of SOPs,, Protocols and Reports, QRMs, Trends, APQR, etc 
4.Handing QMS (Deviation, Change Control, and CAPA) related activities through electronics system i.e. Track wise.

Professional Experience & Skills Required:
1.Experience in Sterile Injectable / Drug Substance Manufacturing site
2.Experience in QMS/ Investigation role with sound understanding of Change Management, Deviation Management and CAPA systems
3.Understanding / Experience in handling TrackWise or similar QMS Applications, Electronic Document Management and Training Management Applications 


3. QA- QMS - M.Sc / M. Pharm with 4 to 6 years’ experience

Job Description:
1.Monitor and collate Quality Metrics and other data.
2.Handle QMS activities line Change Control, Deviations, CAPA.
3.Preparation of SOP, Protocols and Reports
4.Preparation of APQR, QMS Trends, Validation Reports

Professional Experience & Skills Required
1.Experience in IPQA/QMS in injectable manufacturing site
2.Understanding / Experience in handling TrackWise or similar QMS Applications, Electronic Document Management and Training Management Applications.

Job Location: Doddaballapur, Bengaluru.

Please share your Cvs to Nikhila.Pakalapati@arcolab.com, if you wish to apply. 

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