Walk-in for Stelis Biopharma on 16/12/2017

Job Posted on Dec 13, 2017

Job Type:Walk-in
Recruiter Type:Company
Company Name:Stelis Biopharma
Interview Venue:Stelis Biopharma Pvt Ltd
Jigani Link Road, Jigani Bangalore
India
Contact Person:Jason
Phone:9611890198
Email:jason.a@stelis.com
Required in:Formulation Unit
Job Department(s):Quality Control, Engineering
Job Details:Quality Control
• QMS systems preparation & implementation.
• Must have directly faced USFDA, WHO, MHRA, TGA, etc. audits.
• Aware of all the regulatory guidelines & requirements of USFDA, WHO, MHRA, TGA, etc.
• Worked in cGMP facility.
• Aware of all ASMEBPE, ISPE, ISO, etc. guidelines.
• Hands on experience in preparation for SLIA, CLIA, QRM, URS, DQ, IQ, OQ, SOP, PM, BM, RDS & Risk assessments

Engineering
• Experience in handling Electrical Projects & Maintenance in manufacturing setup.
• Should have experience in handling breakdown & Maintenance of electrical equipments.
• Should have experience in handling black utilities and HT & LT Panel installation & commissioning.
• Power house/Utility, DP block, DS block, HVAC
• Execute automation & instrumentation systems as per URS.
• Understand & follow the Master validation plan for CSV.
• Interaction with contractors, equipment manufacturers, user departments during execution as per process requirements.
• Execution as per Hardware & Software design specification (HDS/SDS) as well as automation layout
Regulatory Exposure:Required
Audit Experience:USFDA, MHRA, TGA, MCC, EMA, UNCST, ANVISA, WHO, HC
Experience:2-6 years
Vacancies:9
Interview Date:16/12/2017







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