Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC.
Post : Formulation QC - Stability Testing & Operations
Skill set required
• Must have Working experience in QC with reputed pharmaceutical company/CRO engaged with stability testing catering needs for US & EU markets (Commercial & Registration) for finished dosage forms, especially injectables & IV products
• Must have thorough knowledge in compendial requirements and conducting investigations for Deviations, OOS,OOT, OOC and laboratory incidents
• Expertise in running stability studies for regulated markets for Injectibles and parenteral formulation by using HPLC, UPLC, GC with EMPOWER -3, Auto Tiltrotor, Weight-Loss, Particle size analyzers, UV, FTIR,DSC, Particulate matter Analysis and Polari Meter.
• Should have abilities in Qualification, Calibration and trouble shooting of analytical instruments (list as above)
• Should have applicable knowledge in cGMP, ICH, USP and regulatory requirements.
• Working experience in 21CFR part 11 compliance environment and Data Integrity practices
• Working experience with LIMS under compliance environment is must
• Working experience with MNCs and association with teams engaged with USFDA, MHRA, EUGMP, TGA inspections is highly desirable
• Must have command on written and oral communication skills; especially in the technical report writing
• Personnel with working experience in Qualification, Maintenance and Calibration of stability chambers and familiar with sample management aspects through LIMS can also attend the interview.
Qualification & Experience Range: M.Sc (Exp.: 2-4 Years) /M. Pharm (Emp.: 2-3 Years)
WALK IN INTERVIEW
Date: 11 Feb 2018 (Sunday)
Time: 08.30AM onwards
Venue: The Gateway Hotel
309, Old mahabalipuram Road, Sholinganallur
Chennai-600119
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